Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Lot numbers, UPCs & expiration codes
XP9004, exp 12/2020
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-1356-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 5, 2020
- FDA report date
- Jul 1, 2020
- Quantity
- 11279 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Marksans Pharma Limited
Original FDA data
Every field from FDA enforcement report D-1356-2020, exactly as published.
Show all FDA fields
- City
- Vasco Da Gama
- Status
- Terminated
- Country
- India
- Event ID
- 85818
- Address
- & L - 83 Plots L - 82
- Address (line 2)
- Verna, Goa
- Code information
- XP9004, exp 12/2020
- Report date
- Jul 1, 2020
- Product type
- Drugs
- Recall number
- D-1356-2020
- Classification
- Class II
- Recalling firm
- Marksans Pharma Limited
- Product quantity
- 11279 bottles
- Termination date
- Sep 7, 2023
- Reason for recall
- CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 5, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jun 25, 2020