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 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
Lot numbers, UPCs & expiration codes
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
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-0692-2018
- 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-0692-2018, 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) 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
- Postal code
- 11735-3921
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0692-2018
- 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 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 22, 2018