Reported May 2, 2018 · Terminated
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) 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 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx
- Manufactured forTime Cap labs, Inc., Farmingdale, NY 11735, USA
- Manufactured byMarksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
- Lot codes and dates
a) M104Cexp 9/18L016CH092Cand H093Cexp 9/18 b) C128CC129CC130CC132Cexp 3/18HK6011exp 7/18L016C and H092Cexp 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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