Caraco Pharmaceutical Laboratories, Ltd.

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
D-1511-2014Class IICephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-couJune 26, 2014
D-1510-2014Class IICephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-couJune 26, 2014
D-1415-2014Class IIVenlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 CouJune 12, 2014
D-1407-2014Class IIGemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use VialApril 9, 2014
D-1296-2014Class IIICetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, GuApril 9, 2014
D-1297-2014Class IIIChildren's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured byApril 9, 2014
D-1284-2014Class IIVenlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41March 20, 2014
D-1283-2014Class IIVenlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 416March 20, 2014
D-1081-2014Class IIOxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical LJanuary 29, 2014
D-1089-2014Class IIMetformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: SJanuary 28, 2014
D-089-2013Class IItraMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun PharmNovember 5, 2012
D-003-2013Class IINimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 August 21, 2012