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Class II: temporary or reversible health riskOngoing

Nostrum Laboratories Metformin Hydrochloride Extended-Release Recall

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only

Nostrum Laboratories Inc · Kansas City, MO

Risk level
Class II
Reported by FDA
Nov 11, 2020
Recall ID
D-0067-2021
Check your lot numberHow we source this data

Summary

Nostrum Laboratories recalled Metformin Hydrochloride Extended-Release starting Oct 23, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0067-2021 on Nov 11, 2020. Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level. Status: Ongoing.

Why it was recalled

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Product description

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01

Lot numbers, UPCs & expiration codes

MET200101, MET200301 EXP 05/2022

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-0067-2021
Classification
Class II
Status
Ongoing
Recall initiated
Oct 23, 2020
FDA report date
Nov 11, 2020
Quantity
12,967 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Nostrum Laboratories Inc

Original FDA data

Every field from FDA enforcement report D-0067-2021, exactly as published.

Show all FDA fields
City
Kansas City
State
MO
Status
Ongoing
Country
United States
Event ID
86653
Address
1800 N Topping Ave
Code information
MET200101, MET200301 EXP 05/2022
Postal code
64120-1228
Report date
Nov 11, 2020
Product type
Drugs
Recall number
D-0067-2021
Classification
Class II
Recalling firm
Nostrum Laboratories Inc
Product quantity
12,967 bottles
Reason for recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Voluntary / mandated
Voluntary: Firm initiated
Product description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Distribution pattern
Nationwide
Recall initiation date
Oct 23, 2020
Initial firm notification
Letter
Center classification date
Nov 5, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0067-2021, published Nov 11, 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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