Home / Recalls / Time-Cap Laboratories, Inc. / D-0688-2018

D-0688-2018 Class II Terminated

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

FDA drug recall D-0688-2018 was initiated by Time-Cap Laboratories, Inc. on Jan 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 Jan 20, 2021).

Recall details

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

Product description

Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate 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

C128C, C129C, exp 3/18

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0688-2018
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Time-Cap Laboratories, Inc.

D-0694-2018 Class II — Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets… (Jan 11, 2018)
D-0691-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet… (Jan 11, 2018)
D-0690-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500… (Jan 11, 2018)
D-0687-2018 Class II — Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet… (Jan 11, 2018)
D-0695-2018 Class II — Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets… (Jan 11, 2018)
D-0686-2018 Class II — Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet… (Jan 11, 2018)
D-0693-2018 Class II — Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet… (Jan 11, 2018)
D-0692-2018 Class II — Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet… (Jan 11, 2018)
D-0689-2018 Class II — Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet… (Jan 11, 2018)
D-0685-2018 Class II — Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets… (Jan 11, 2018)