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Class II: temporary or reversible health riskOngoing

amneal Metformin Hydrochloride Recall

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distribute…

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Risk level
Class II
Reported by FDA
Jul 1, 2020
Recall ID
D-1354-2020
Check your lot numberHow we source this data

Summary

Amneal Pharmaceuticals of New York recalled amneal Metformin Hydrochloride starting May 29, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1354-2020 on Jul 1, 2020. Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. Status: Ongoing.

Why it was recalled

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Product description

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

Lot numbers, UPCs & expiration codes

HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1354-2020
Classification
Class II
Status
Ongoing
Recall initiated
May 29, 2020
FDA report date
Jul 1, 2020
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Amneal Pharmaceuticals of New York, LLC

Original FDA data

Every field from FDA enforcement report D-1354-2020, exactly as published.

Show all FDA fields
City
Brookhaven
State
NY
Status
Ongoing
Country
United States
Event ID
85781
Address
50 Horseblock Rd
Code information
HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020
Postal code
11719-9509
Report date
Jul 1, 2020
Product type
Drugs
Recall number
D-1354-2020
Classification
Class II
Recalling firm
Amneal Pharmaceuticals of New York, LLC
Reason for recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Voluntary / mandated
Voluntary: Firm initiated
Product description
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
Distribution pattern
Nationwide
Recall initiation date
May 29, 2020
Initial firm notification
Press Release
Center classification date
Jun 25, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1354-2020, published Jul 1, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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