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, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, 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) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18
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-0685-2018
- 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-0685-2018, 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) D167C, exp 2/18; b) D172C, exp 2/18, H057C, exp 6/18; c) D164C, exp 2/18, E135C, exp 3/18; d) D172C, exp 2/18, E135C, exp 3/18, F004C, exp 5/18; e) D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, E106C, exp 2/18; L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, H056C, exp 5/18; L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, H058C, exp 6/18; L120C, L121C, L122C, L123C, L124C, exp 8/18
- Postal code
- 11735-3921
- Report date
- May 2, 2018
- Product type
- Drugs
- Recall number
- D-0685-2018
- 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, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, 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