Wockhardt Usa Inc.

FDA Regulatory Profile

Summary

Total Recalls
45
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0051-2018Class IIIEnalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt LimitedAugust 22, 2017
D-1347-2015Class IILisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, MumbJuly 29, 2015
D-1346-2015Class IILisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, MumbaJuly 29, 2015
D-1277-2015Class IICaptopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: WocApril 22, 2015
D-1257-2015Class IILisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 CoApril 22, 2015
D-1276-2015Class IICaptopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) April 22, 2015
D-1252-2015Class IIMetoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count BottlesApril 22, 2015
D-1254-2015Class IIZonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: WockApril 22, 2015
D-1251-2015Class IILansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 CApril 22, 2015
D-1264-2015Class IIAzithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: WApril 22, 2015
D-1272-2015Class IIMetoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles April 22, 2015
D-1260-2015Class IILisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B)April 22, 2015
D-1246-2015Class IIExtended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 646April 22, 2015
D-1273-2015Class IIZonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: WockhApril 22, 2015
D-1261-2015Class IILisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 April 22, 2015
D-1249-2015Class IIClarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt LApril 22, 2015
D-1250-2015Class IIFamotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100April 22, 2015
D-1245-2015Class IILamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: WocApril 22, 2015
D-1275-2015Class IICaptopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) April 22, 2015
D-1248-2015Class IIAzithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) April 22, 2015