Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Product description
Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
Lot numbers, UPCs & expiration codes
N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
Where it was sold
Indiana - 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-0056-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 8, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Denton Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0056-2021, exactly as published.
Show all FDA fields
- City
- North Blenheim
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 86593
- Address
- 119 Creamery Rd
- Code information
- N107411901, N107411903, N107411904, N107411905, N107411906, exp 11/30/2020; N107411907, N107412001, exp 4/30/2021; N107412002, N107412004, exp 11/30/2021; N107412003, exp 7/31/2021
- Postal code
- 12131-1613
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0056-2021
- Classification
- Class II
- Recalling firm
- Denton Pharma, Inc.
- Reason for recall
- CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metformin Hydrochloride Extended-Release Tablets USP 750 mg, 30 Tablets bottle, Rx Only, Time-Cap Labs, Inc., Repackaged By: Northwind Pharmaceuticals North Blenheim NY 12131 NDC 70934-334-30
- Distribution pattern
- Indiana - Nationwide.
- Recall initiation date
- Oct 8, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 2, 2020