Recalls / Class II
Class IID-0694-2018
Product
Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 49483-114, 49483-601, 49483-600
- FDA application
- ANDA091239
- Affected lot / code info
- a) F066C b) F066C c) F066C
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.
- Manufacturer
- 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-0694-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.