FDA-Drug2015-07-29Class II
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Wockhardt Usa Inc.
Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints.
Sold states
U.S. Nationwide including Puerto Rico.
Affected count
407,958 Bottles
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1253-2015Don't want to check this manually?
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