Recalls / Class II
Class IID-0061-2021
Product
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) 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 49483-623-50
- 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
- a) 90 count: E072F, E074F, E076F Oct-20; D096F, H029F, H031F,XP8276, XP8289 Nov-20; L007F, J022F, H039F, Dec-20; J092F Jan-21; L055F Jun-21; K079F Jul-21; A002G, A003G, A007G Aug-21; A49001 Nov-21; A40001, A40003, A40005 Dec-21; A40009 Feb-22; A40010, XP0036, A40013 Mar-22; A40015 Apr-22 b) 100 count: XP8260 Oct-20; XP0010, XP0016 Dec-21; XP0046 Apr-22; c) 500 count: E037F, G011F Oct-20; F001F Nov-20; H041F, L009F Dec-20; K051F Jun-21; A115G, A010G Sep-21; A40006, A40007, A40008 Jan-22; A40011 Mar-22; A40016, A40018 Apr-22; d) 1000 count: D086F Oct-20; G012F Nov-20; L008F Dec-20; K042F Feb-21; M001F Jul-21; A009G Sep-21; A40002, A40004 Dec-21; A40012 Mar-22, A40014, A40017 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
- a) 64,590 b) 23,834 c) 109,125 d) 27839 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-0061-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.