Recalls / Class II
Class IID-0689-2018
Product
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 49483-602, 49483-603, 49483-604
- FDA application
- ANDA090796
- Affected lot / code info
- a) C135C, D044C, D045C, D038C, exp 3/18, F069C, exp 4/18, H095C, exp 9/18 b) C134C, C136C, D039C, D040C, D041C, D042C, D043C, exp 3/18, F043C F067C, F068C, D046C, D047C, exp 4/18, H094C, exp 7/18 H096C, L026C, and H095C, exp 9/18
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.
- 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-0689-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.