Reported May 2, 2018 · Terminated
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx,…
Time-Cap Laboratories, Inc.
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: Time-Cap Laboratories, Inc. · 7 Michael Ave · Farmingdale, NY · 11735-3921
Is this the product you have?
- Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx
- Manufactured forTime Cap labs, Inc., Farmingdale, NY 11735, USA
- Manufactured byMarksans Pharma, Ltd., Verna, Goa-403 722, India
- Lot codes and dates
a) C139CC140Cexp 2/18F044Cexp 8/18b) D048CD049CD050CD051CC142CC137CC138CC139CC141Cexp 2/18D052CK207CK208CK209CK210CK211CK212CHM6122HM6123HM6124HM6125HM6126K109CK110CK111CHM6113HM6114HM6115HM6116HM6117HM6118F044CH097CH098CH099CH100CH101CK096CK097CK098CK099CK100CK101CK102Cexp 8/18M105CL017CL018CL019CL020CL021CL022Cexp 9/18
- Amount recalled
- N/A
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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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