Time-Cap Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0690-2018Class IIIbuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582January 11, 2018
D-0688-2018Class IIIbuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal PJanuary 11, 2018
D-0693-2018Class IIIbuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) January 11, 2018
D-0691-2018Class IIIbuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112January 11, 2018
D-0686-2018Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), cJanuary 11, 2018
D-0685-2018Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01)January 11, 2018
D-0689-2018Class IIIbuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-January 11, 2018
D-0687-2018Class IIIbuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) January 11, 2018
D-0695-2018Class IIIbuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), aJanuary 11, 2018
D-0694-2018Class IIIbuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), cJanuary 11, 2018
D-0692-2018Class IIIbuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) January 11, 2018
D-1055-2017Class IIIbuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time CaJune 16, 2017