Reported May 2, 2018 · Terminated
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets…
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?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 50 caplets (NDC 53943-292-15) |
| 2 | 100 caplets (NDC 53493-292-12), and |
| 3 | 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India |
- Lot codes and dates
- a) F066C b) F066C c) F066C
- 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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