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 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
Lot numbers, UPCs & expiration codes
MET100201, MET100401 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-0068-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 23, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 20,872 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nostrum Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-0068-2021, 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
- MET100201, MET100401 EXP 05/2022
- Postal code
- 64120-1228
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0068-2021
- Classification
- Class II
- Recalling firm
- Nostrum Laboratories Inc
- Product quantity
- 20,872 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 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2020