Recalls / Class II
Class IID-0688-2018
Product
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
- Affected lot / code info
- C128C, C129C, exp 3/18
Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recalling firm
- Firm
- Time-Cap Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Michael Ave, N/A, Farmingdale, New York 11735-3921
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-01-11
- FDA classified
- 2018-04-22
- Posted by FDA
- 2018-05-02
- Terminated
- 2021-01-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0688-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.