Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Product description
Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only 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 Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
Lot numbers, UPCs & expiration codes
M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
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-0062-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 368,976 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Marksans Pharma Limited
Original FDA data
Every field from FDA enforcement report D-0062-2021, exactly as published.
Show all FDA fields
- City
- Vasco Da Gama
- Status
- Terminated
- Country
- India
- Event ID
- 86530
- Address
- & L - 83 Plots L - 82
- Address (line 2)
- Verna, Goa
- Code information
- M125E Oct-20; D001F, C084F Nov-20; F073F, E063F Jan-21; F072F Mar-21; J002F, J087F Apr-21; K080F, L056F Jun 21; M046F, Jul-21; 9R9001, Oct-21; 9R9002, Nov-21; 9R0001, 9R0002 Dec-21; 9R0003, XR0016, 9R0004, 9R0005 Mar-22; 9R0006, 9R0007 Apr-22
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0062-2021
- Classification
- Class II
- Recalling firm
- Marksans Pharma Limited
- Product quantity
- 368,976 bottles
- Termination date
- Feb 21, 2024
- Reason for recall
- CGMP Deviations: detection of 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 750 mg, 100 count bottles, Rx Only 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 Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 2, 2020
- Initial firm notification
- Press Release
- Center classification date
- Nov 2, 2020