Reported May 2, 2018 · Terminated
Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets…
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?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | 50 tablets (NDC 49483-601-05) |
| 2 | 100 tablets (NDC- 49483-601-01) |
| 3 | 500 tablets (NDC 49483-601-50) |
| 4 | 1000 tablets (NDC 49489-601-10) |
| 5 | Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 D167C, exp 2/18 2 D172C, exp 2/18, H057C, exp 6/18 3 D164C, exp 2/18, E135C, exp 3/18 4 D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18 5 D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18 - 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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