Reported Nov 11, 2020 · Terminated
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100…
Marksans Pharma Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Marksans Pharma Limited · & L - 83 Plots L - 82 · Vasco Da Gama, N/A · N/A
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | 90 count (NDC 49483-623-09) |
| 2 | 100 count (49483-623-01) |
| 3 | 500 count (NDC 49483-623-50) and |
| 4 | 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 |
- Lot codes and dates
30 of 30 products
Products covered by this recall # Product as published 1 E072F, E074F, E076F Oct-20 2 D096F, H029F, H031F,XP8276, XP8289 Nov-20 3 L007F, J022F, H039F, Dec-20 4 J092F Jan-21 5 L055F Jun-21 6 K079F Jul-21 7 A002G, A003G, A007G Aug-21 8 A49001 Nov-21 9 A40001, A40003, A40005 Dec-21 10 A40009 Feb-22 11 A40010, XP0036, A40013 Mar-22 12 A40015 Apr-22 b) 100 count: XP8260 Oct-20 13 XP0010, XP0016 Dec-21 14 XP0046 Apr-22 15 500 count: E037F, G011F Oct-20 16 F001F Nov-20 17 H041F, L009F Dec-20 18 K051F Jun-21 19 A115G, A010G Sep-21 20 A40006, A40007, A40008 Jan-22 - Amount recalled
- a) 64,590 b) 23,834 c) 109,125 d) 27839 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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