- Company Announcement Date:
- May 29, 2020
- FDA Publish Date:
- June 01, 2020
- Product Type:
- Reason for Announcement:
Recall Reason Description
Due to detection of N-Nitrosodimethylamine (NDMA)
- Company Name:
- Amneal Pharmaceuticals LLC
- Brand Name:
- Product Description:
Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg
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 Retail 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.
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 found in water and foods, including meats, dairy products and vegetables.
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|
|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||1000 count bottles|
|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.
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.
Customers who purchased the impacted product directly from Amneal may call Amneal at 1-833-582-0812 or email to [email protected], Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.
Retailers who have Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which are being recalled, should cease dispensing and contact Inmar at 855-532-1851 or via email at [email protected] Monday – Friday, 8:00 am – 5:00 pm, EST, to arrange for 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 [email protected].
Any 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.
- 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Safe Harbor Statement
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including, among other things, future operating results and financial performance, product development and launches, integration strategies and resulting cost reduction, market position and business strategy. Words such as “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “assume,” “continue,” and similar words are intended to identify estimates and forward-looking statements.
The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Amneal Pharmaceuticals, Inc. (the “Company”). Such risks and uncertainties include, but are not limited to, risks related to the products and recall thereof described in this press release. A further list and descriptions of these risks, uncertainties and other factors can be found in the Company’s most recently filed Annual Report on Form 10-K for the fiscal year ended December 31, 2019 as supplemented by any subsequently filed Quarterly Reports on Form 10-Q. Copies of these filings are available online at www.sec.gov,www.amneal.com or on request from the Company.