Recalls / Class II
Class IID-0062-2021
Product
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
- 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
- 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
Why it was recalled
CGMP Deviations: detection of 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
- 368,976 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2020-10-02
- FDA classified
- 2020-11-02
- Posted by FDA
- 2020-11-11
- Terminated
- 2024-02-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0062-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.