Home / Recalls / Time-Cap Laboratories, Inc. / D-0685-2018

D-0685-2018 Class II Terminated

Recalled by Time-Cap Laboratories, Inc. — Farmingdale, NY

Recall Details

Product Type
Drugs
Report Date
May 2, 2018
Initiation Date
January 11, 2018
Termination Date
January 20, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

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

Reason for Recall

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

Distribution Pattern

Nationwide.

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

Other recalls by Time-Cap Laboratories, Inc.

  • D-0690-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 table (January 11, 2018)
  • D-0688-2018 Class II — Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distrib (January 11, 2018)
  • D-0693-2018 Class II — Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (January 11, 2018)
  • D-0691-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bo (January 11, 2018)
  • D-0686-2018 Class II — Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet ( (January 11, 2018)
  • D-0689-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet (January 11, 2018)
  • D-0687-2018 Class II — Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (January 11, 2018)
  • D-0695-2018 Class II — Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets ( (January 11, 2018)
  • D-0694-2018 Class II — Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets ( (January 11, 2018)
  • D-0692-2018 Class II — Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (January 11, 2018)