Home / Recalls / Time-Cap Laboratories, Inc. / D-0694-2018

D-0694-2018 Class II Terminated

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

FDA drug recall D-0694-2018 was initiated by Time-Cap Laboratories, Inc. on January 11, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. The recall status is terminated (terminated January 20, 2021). Affected quantity: N/A.

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 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

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) F066C b) F066C c) F066C

Other recalls by Time-Cap Laboratories, Inc.

  • D-0692-2018 Class II — Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (January 11, 2018)
  • 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-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-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-0685-2018 Class II — Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (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)

FDA data resources