Time-Cap Laboratories, Inc.: 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 117

Is my product affected?

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 IBUPROFEN

Check against the official notice below — it lists the full affected range.

What happened

Time Cap Laboratories is recalling Ibuprofen Tablets USP 800 mg in two package sizes: 100-tablet bottles (NDC 49483-604-01) and 500-tablet bottles (NDC 49483-604-50). The recall affects multiple lot numbers distributed nationwide and is due to complaints of odor related to Current Good Manufacturing Practice (CGMP) deviations in how the medication was produced.

The affected lot codes for the 100-tablet bottles are C139C, C140C, and F044C (expiring 2/18 and 8/18). The 500-tablet bottles have numerous affected lots expiring between 2/18 and 9/18, including codes such as D048C through D051C, C142C, C137C through C139C, C141C, D052C, K207C through K212C, and various other designations. The source document does not specify what remedy is available to affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

Details from the source

Reason for recall: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Distribution: Nationwide. Quantity: N/A 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 2018-01-11
• 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, India2018-01-11
• Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.2018-01-09
• Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-92019-09-27
• Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-612022-04-13

All FDA (Drug enforcement) recalls