Recalls / Class II
Class IID-1356-2020
Product
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
- Brand name
- Metformin Hydrochloride Extended Release
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 49483-623, 49483-624
- FDA application
- ANDA090295
- Affected lot / code info
- XP9004, exp 12/2020
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- Marksans Pharma Limited
- Manufacturer
- TIME CAP LABORATORIES, INC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- & L - 83 Plots L - 82, Verna, Goa, Vasco Da Gama, N/A N/A, India
Distribution
- Quantity
- 11279 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-06-05
- FDA classified
- 2020-06-25
- Posted by FDA
- 2020-07-01
- Terminated
- 2023-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1356-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.