FDA-Drug2015-07-29Class II
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), 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
A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
Manufactured in
20 Waterview Blvd Ste 3, N/A, Parsippany, NJ, United States
Products
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), 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-1269-2015Don't want to check this manually?
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