Why it was recalled
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Product description
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
Lot numbers, UPCs & expiration codes
a) F066C b) F066C c) F066C
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0694-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2018
- FDA report date
- May 2, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Time-Cap Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0694-2018, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 79349
- Address
- 7 Michael Ave
- Code information
- a) F066C b) F066C c) F066C
- Postal code
- 11735-3921
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0694-2018
- Classification
- Class II
- Recalling firm
- Time-Cap Laboratories, Inc.
- Termination date
- Jan 20, 2021
- Reason for recall
- CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 22, 2018