PRODUCT RECALLS

STATES:  Nationwide

 

RECALLS:   Four (4) Companies-Metformin Hydrochloride Extended-Release TabletDue to detection of N-Nitrosodimethylamine (NDMA)

 

  • Brand Name:  Apotex Corp

     Company Name:  Apotex Corp

     Product:  USP 500mg

  • Brand Name:  Actavis

     Company Name:  Teva Pharmaceuticals USA Inc. 

     Product:  USP 500 mg

  • Brand Name: Time-Cap Labs, Inc.   

      Company Name:  Marksans Pharma Limited, India

      Product USP 500 mg

  • Brand Name:  Amneal

     Company Name:  Amneal Pharmaceuticals LLC

     Product:  USP 500mg and 750mg

 

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

STATES:  Nationwide

 

RECALLS:   Four (4) Companies-Metformin Hydrochloride Extended-Release TabletDue to detection of N-Nitrosodimethylamine (NDMA)

 

  • Brand Name:  Apotex Corp

     Company Name:  Apotex Corp

     Product:  USP 500mg

  • Brand Name:  Actavis

     Company Name:  Teva Pharmaceuticals USA Inc. 

     Product:  USP 500 mg

  • Brand Name: Time-Cap Labs, Inc.   

      Company Name:  Marksans Pharma Limited, India

      Product USP 500 mg

  • Brand Name:  Amneal

     Company Name:  Amneal Pharmaceuticals LLC

     Product:  USP 500mg and 750mg

 

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

 

Apotex

 

 

 

 

 

 

 

 

 

is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level.

 

Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

 

Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

 

Product                                                                                 Strength     Pack Size     NDC Number

Metformin Hydrochloride Extended-Release Tablets,USP   500mg      100's Bottle   60505-0260-1

 

The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

 

ACTION & CONTACT:   Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, contact their health care provider for medical advice and should return the impacted product to their pharmacist.

 

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. 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.

 

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

 

                                                         Teva Pharmaceuticals USA, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

 

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

 

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

 

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

 

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

 

NDC                      Product Description                                          Lot Number          Expiration

62037-571-01     Metformin Hydrochloride Extended-Release     1329548A             06/2020 

                        Tablets, USP 500 mg 100 Count

 

62037-571-01     Metformin Hydrochloride Extended-Release     1338302M            10/2020

                        Tablets, USP 500 mg 100 Count

 

62037-571-01     Metformin Hydrochloride Extended-Release     1348968M            10/2020     

                        Tablets, USP 500 mg 100 Count

 

62037-571-01     Metformin Hydrochloride Extended-Release     1348969M            11/2020 

                        Tablets, USP 500 mg 100 Count

 

62037-571-01     Metformin Hydrochloride Extended-Release     1348970M            10/2020

                        Tablets, USP 500 mg 100 Count

 

62037-571-01     Metformin Hydrochloride Extended-Release     1376339M            09/2021

                        Tablets, USP 500 mg 100 Count

 

62037-571-10     Metformin Hydrochloride Extended-Release     1323460M            06/2020

                        Tablets, USP 500 mg 1000 Count

 

62037-571-10     Metformin Hydrochloride Extended-Release     1330919M            06/2020 

                        Tablets, USP 500 mg 1000 Count

 

62037-571-10     Metformin Hydrochloride Extended-Release     1338300A            10/2020

                        Tablets, USP 500 mg 1000 Count

 

62037-571-10     Metformin Hydrochloride Extended-Release     1341135M            12/2020

                        Tablets, USP 500 mg 1000 Count

 

62037-571-10     Metformin Hydrochloride Extended-Release     1391828M            11/2021 

                        Tablets, USP 500 mg 1000 Count

 

62037-577-01     Metformin Hydrochloride Extended-Release     1333338M            08/2020

                        Tablets, USP 750 mg 100 Count

 

62037-577-01     Metformin Hydrochloride Extended-Release     1333339A            08/2020

                        Tablets, USP 750 mg 100 Count

 

62037-577-10     Metformin Hydrochloride Extended-Release     1354471A            02/2021 

                        Tablets, USP 750 mg 1000 Count

 

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals.  Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

 

ACTION & CONTACT:  Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: tevarecalls@inmar.com.

Inmar will provide the materials needed to return their medication and instructions for reimbursement.

 

Marksans Pharma Limited, India

 

 

 

 

 

 

is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

 

Marksans Pharma Limited has not received any reports of adverse events related to this recall to date.

 

Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

 

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg

Lot #: XP9004

Expiry Date (MM/YYYY): 12/2020

 

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.

 

Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot. Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase.

 

ACTION & CONTACT: Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address imcgregor@timecaplabs.com.

 

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.

 

Amneal Pharmaceuticals LLC

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level.

 

Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

 

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

 

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

 

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

 

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

 

Metformin HCl Extended Release Tablets, USP, 500 mg

53746-178-01                                     100 count bottles                                                         53746-178-05                                     500 count bottles

53746-178-10                                    1000 count bottles

53746-178-90                                       90 count bottles 

53746-178-Bulk                                               Bulk Box

65162-178-09                                       90 count bottles

65162-178-10                                     100 count bottles

65162-178-11                                   1000 count bottles  

65162-178-50                                     500 count bottles     

 

Metformin HCl Extended Release Tablets, USP, 750 mg

53746-179-01                                   100 count bottles                                   

53746-179-Bulk                                             Bulk Box 

65162-179-10                                   100 count bottles

 

 

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.

 

ACTION & CONTACT:  Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to AmnealProductRecallDS@amneal.com, Monday – Friday, 8:00 am – 5:00 pm, EST, for further information

 

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

 

Pharmacies should cease dispensing product.  Amneal is notifying Retailers via mail (UPS Standard Overnight) who have been provided Amneal’s Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which will include instructions for retailer and consumer product return.

 

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com.

 

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Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online

  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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