Recalls / Class II
Class IID-0692-2018
Product
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., 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) C139C, C140C, exp 2/18, F044C, exp 8/18; b) D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, C141C, exp 2/18; D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, K102C, exp 8/18; M105C, L017C, L018C, L019C, L020C, L021C, L022C, 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-0692-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.