Drug Recalls

On November 29, 2022 -

FOR IMMEDIATE RELEASE – November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022.

 

Brand Lot Expire Date
Exela P0001178 05/2023
Exela P0001298 08/2023
Exela P0001301 08/2023
Exela P0001313 08/2023
Exela P0001314 08/2023
Exela P0001317 08/2023
Exela P0001330 09/2023
Exela P0001370 10/2023
Exela P0001371 10/2023
Exela P0001372 10/2023
Exela P0001433 11/2023
Exela P0001434 11/2023
Exela P0001442 11/2023
Exela P0001443 12/2023
Exela P0001464 09/2023
Exela P0001467 12/2023
Exela P0001468 12/2023
Exela P0001469 12/2023
Exela P0001470 12/2023
Exela P0001472 12/2023
Exela P0001486 12/2023
Exela P0001495 12/2023
Exela P0001505 12/2023
Exela P0001506 12/2023
Exela P0001509 12/2023
Exela P0001510 12/2023
Exela P0001511 12/2023
Exela P0001512 12/2023
Exela P0001532 12/2023
Exela P0001560 01/2024
Exela P0001561 01/2024
Exela P0001562 01/2024
Exela P0001564 01/2024
Exela P0001566 01/2024
Exela P0001567 01/2024
Exela P0001568 01/2024
Exela P0001571 02/2024
Exela P0001572 02/2024
Exela P0001573 02/2024
Exela P0001574 02/2024
Exela P0001578 02/2024
Exela P0001579 02/2024
Exela P0001580 02/2024
Exela P0001583 02/2024
Exela P0001586 02/2024
Exela P0001587 02/2024
Exela P0001588 02/2024
Exela P0001593 02/2024
Exela P0001594 02/2024
Exela P0001610 02/2024
Exela P0001618 02/2024
Exela P0001619 02/2024
Exela P0001644 03/2024
Exela P0001645 03/2024
Exela P0001646 03/2024
Exela P0001654 02/2024
Civica P0001490 12/2023
Civica P0001497 12/2023
Civica P0001600 02/2024
Civica P0001663 03/2024


The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.

Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
 

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.



For more information about this recall, please visit the FDA website



On October 25, 2022 -

Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.

Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.

 

NDC No.

Product Name, strength, and pack

Lot number

Expiry

65862-162-90

Quinapril and Hydrochlorothiazide
Tablets USP, 20mg / 12.5mg,
90’s HDPE bottle

QE2021005-A

01/2023

QE2021010-A


Risk Statement: Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.

The product label is as shown below:

Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.



For more information about this recall, please visit the FDA website



On October 17, 2022 -

Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:

  • Battery swelling
  • Fluid leakage from the battery
  • Extreme overheating that may pose a fire hazard

Users could be exposed to battery fluid and extreme heat, including the potential for an explosion and/or fire, which could lead to serious injury or death.



For more information about this recall, please visit the FDA website



On October 14, 2022 -

Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level.

Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.

The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).

The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
 

Brand

Lot

Expire Date

Exela

P0001370

10/2023

Exela

P0001371

10/2023

Exela

P0001372

10/2023

Exela

P0001433

11/2023

Exela

P0001434

11/2023

Exela

P0001443

12/2023

Exela

P0001468

12/2023

Exela

P0001469

12/2023

Exela

P0001470

12/2023

Exela

P0001495

12/2023

Exela

P0001505

12/2023

Exela

P0001506

12/2023

Exela

P0001509

12/2023

Exela

P0001510

12/2023

Exela

P0001511

12/2023

Exela

P0001512

12/2023

Exela

P0001560

01/2024

Exela

P0001561

01/2024

Exela

P0001562

01/2024

Exela

P0001564

01/2024

Exela

P0001566

01/2024

Exela

P0001567

01/2024

Exela

P0001568

01/2024

Exela

P0001571

02/2024

Exela

P0001572

02/2024

Exela

P0001573

02/2024

Exela

P0001574

02/2024

Exela

P0001578

02/2024

Exela

P0001579

02/2024

Exela

P0001580

02/2024

Exela

P0001583

02/2024

Exela

P0001586

02/2024

Exela

P0001587

02/2024

Exela

P0001588

02/2024

Exela

P0001593

02/2024

Exela

P0001594

02/2024

Exela

P0001610

02/2024

Exela

P0001618

02/2024

Exela

P0001619

02/2024

Exela

P0001644

03/2024

Exela

P0001645

03/2024

Exela

P0001646

03/2024

Exela

P0001654

02/2024

Exela

P0001662

03/2024

Exela

P0001664

03/2024

Exela

P0001730

05/2024

Civica

P0001497

12/2023

Civica

P0001600

02/2024

Civica

P0001663

03/2024


The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.

The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.

All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.

Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.

Customers with questions regarding this recall can contact Exela by phone (828-341-6118 x1017) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.



For more information about this recall, please visit the FDA website



On September 29, 2022 -

Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.



For more information about this recall, please visit the FDA website



On July 15, 2022 -

Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level.  The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Gluconacetobacter liquefaciens.



Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall.  Vi-Jon, LLC is in the process of investigating this report.



The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.



The list of affected brands can be viewed on the FDA website.



For more information about this recall, please visit the FDA website



On July 05, 2022 -

Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022. The recalled batch information is as follows:
 

NDC #

Name and Strength

Size

Batch #

Expiry

49502-394-75

Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)

3 mL Prefilled Pen

BF21002895

Aug 2023


The company has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:
 

  • Wholesalers: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list via Microsoft Excel file to mylan8775@sedgwick.com within five (5) business days. Sedgwick will notify your retail level customers that received the affected batch.

  • Retailers: Immediately examine your inventory, quarantine and discontinue distribution of this batch. In addition, if you have further distributed the subject batch, please identify the consumer and notify them of this product recall and to immediately return any unlabeled product per the instructions below.

  • Consumers: If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.



For more information about this recall, please visit the FDA website



On June 21, 2022 -

Smyrna, TN, Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefacien.

Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, Vi-Jon, LLC has not received any complaints related to this recall.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd Party Outside Lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.

Vi-Jon, LLC has already notified CVS by phone and email and is arranging for return of all recalled product.

Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail Recalls@Vijon.com Monday-Friday, from 7:30 am to 4:30 pm Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.



For more information about this recall, please visit the FDA website



On May 23, 2022 -

Parsippany, NJ. Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg (Lot number GD01090), to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution – taking longer to dissolve once ingested -- may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide available in the body. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening. To date, Teva has not received any product quality complaints or adverse event reports, of this nature, for the recalled lot.

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. Information about the affected lot is listed in the table below. It is packed in bottles with 100 Capsules. Teva distributed 4224 bottles nationwide from 07-30-2020 through 09-02-2020 to its wholesale, distributor and retail customers under the label for Teva Pharmaceuticals USA, Inc.
 

NDC

Lot #

Exp. Date

0172-5241-60

GD01090

05/2022


Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Instructions for returning recalled product and receiving a credit are given in the customer recall letter (Anagrelide Recall 05 2022 Direct Accounts Letter Consumer Level 20 MAY 2022.pdf) External Link Disclaimer and consumer recall letter (Anagrelide Recall 05 2022 _Patient Letter 20 MAY 2022.pdf External Link Disclaimerreleased by Teva.



For more information about this recall, please visit the FDA website



On April 22, 2022 -

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Accupril is indicated for the treatment of hypertension, to lower blood pressure.  Accupril is also indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics and/or digitalis. Accupril has a safety profile that has been established over 30 years. To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Pfizer believes the benefit/risk profile of the products remains positive based on currently available data. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

The NDC, Lot Number, Expiration Date, and Configuration details for these products are indicated in the tables below and photos of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022.

Accupril® (Quinapril HCl Tablets), 10 mg
Accupril® (Quinapril HCl Tablets), 20 mg
Accupril® (Quinapril HCl Tablets), 40 mg
 

NDC

Lot Number

Expiration
Date

Strength

Configuration/
Count

0071-0530-23

DR9639

2023 MAR 31

10 mg

1 x 90 count bottle

0071-0532-23

DX8682

2023 MAR 31

20 mg

1 x 90 count bottle

DG1188

2022 MAY 31

20 mg

1 x 90 count bottle

0071-0535-23

DX6031

2023 MAR 31

40 mg

1 x 90 count bottle

CK6260

2022 MAY 31

40 mg

1 x 90 count bottle


Pfizer places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Pfizer has notified direct consignees by letter to arrange for return of any recalled product.

Wholesalers and distributors with an existing inventory of the lots, listed in the table above, should stop use and distribution and quarantine the product immediately.

If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the affected product and promptly contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) to obtain a Business Reply Form (BRF) to initiate the return process.

If you received free product through the Pfizer Patient Assistance Program (PAP) or the Pfizer Institutional Patient Assistance Program (IPAP), please check your stock immediately against the table above. If you have any of the affected product lots in your inventory, please follow the instructions above for returning the product to Sedgwick. Additionally, if you are aware of any patients to whom you dispensed the affected lots who still may have the product in their possession, please ask them to return the product to you and then follow the instructions above for returning the product to Sedgwick. To request replacement product for any Pfizer PAP or Pfizer IPAP product you return, please contact 833-203-2776 (Mon.-Fri. 8 am-6 pm ET).

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-345-0481 (Mon.-Fri. 8:00 am - 5:00 pm ET) for instructions on how to return their product and obtain reimbursement for their cost.​



For more information about this recall, please visit the FDA website



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Drug Recall Process

The U.S. Food and Drug Administration (FDA) has jurisdiction over food, drugs, cosmetics, medical devices and other products and services as a monitor over product recalls. In most cases recalls are done voluntarily by the manufacturer or the distributor of the product. In some cases, a company will discover that one of its products is defective and will recall it. In other cases, the FDA will notify a company that one of its products is defective and will suggest or request a recall.

The FDA has guidelines for companies to follow in recalling defective products. These guidelines explain that the FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. The guidelines categorize all recalls into one of the three classes according to the level of hazard involved.

  • Class I recalls are for dangerous or defective products that predictably could cause serious health problems or death.
  • Class II recalls are for products that might cause a temporary health problem, or pose only a slight threat of a serious nature.
  • Class III recalls are for products that are unlikely to cause any adverse health reaction, but that violates FDA regulations.


Navitus Health Solutions LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.

 

This plan, Navitus MedicareRx (PDP), is offered by Navitus Health Solutions and underwritten by Dean Health Insurance, Inc., A Federally-Qualified Medicare Contracting Prescription Drug Plan.