Home / Recalls / Time-Cap Laboratories, Inc. / D-1055-2017

D-1055-2017 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
June 16, 2017
Termination Date
May 29, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,980 bottles

Product Description

Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50

Reason for Recall

Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.

Distribution Pattern

Nationwide U.S.A.

Code Information

Lot #: HN7003

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-0685-2018 Class II — Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (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)