Amneal recalls Metformin Hydrochloride Extended Release Tablets to consumer level
Posted: 5 June 2020 | Hannah Balfour (European Pharmaceutical Review) | 8 comments
The voluntary recall of Metformin Hydrochloride Extended Release Tablets, 500mg and 750mg is due to unacceptable levels of NDMA impurities.
Amneal Pharmaceuticals LLC is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500mg and 750mg, within expiry to the consumer level due to N-Nitrosodimethylamine (NDMA) impurities.
The enterprise was notified by the US Food and Drug Administration (FDA) that testing of seven lots of the tables showed NDMA in amounts above the acceptable FDA levels. Amneal agreed with the FDA recommendation that lots of these tablets be recalled.
To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.
According to the company, the lots were distributed across the US to wholesalers, distributors, retailers and repackagers. Amneal is notifying its direct customers 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. The company said instructions on how retailers and consumers should return products will be included in the notification letters. Customers wishing to know more and where to contact Amneal can find more information here.
Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.
The list of affected lots is below:
Metformin HCl Extended Release Tablets, USP, 500mg
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, 750mg
53746-179-01 | 100 count bottles |
53746-179-Bulk | Bulk Box |
65162-179-10 | 100 count bottles |
Related topics
Related organisations
Amneal Pharmaceuticals Inc, US Food and Drug Administration (FDA)
I need a prepaid shipping label to return recalled Metformin. I have tried e-mailing and calling, with no response to my e-mails and the phone not being answered. Please advise how to proceed.
I received a letter instructing me to stop taking the Metformin and get a replacement drug, then call or e-mail Amneal to get the recalled drug returned and reimbursed. Neither a phone call or e-mail accomplished this. Please advise.
I am requesting shipping label to return 4 bottles of metformin.
I just received the recall letter from CVS CAREMARK yesterday. The “Lot” numbers you may be looking for are on the white Amneal bottle with a pinkish label: The NDC number, right above the “Metformin” main label, is whats listed in the above table. I went back through my CVS shipping receipts and find that I have been taking a recalled NDC lot for 9 months now. Not at all happy about it!
I need a shipping label to return Metformin
I have been trying to contact Amneal at the toll-free number and the e-mail address given in the recall letter and both are not available. I am trying to receive the pre-paid shipping label to return the Metformin that is involved with the recall. I do not wish to receive a reimbursement as my copay was covered by the insurance.
Received letter from CVS CAREMARK to email due to the recall of metformin HCL ER 500 MG tablets for a request to send prepaid shipping label for return to you. Please let me know what information I need to provide to get recalled product returned ASAP.
where do I find lot number