RecallWatchUSA

Home / Recalls / Drugs

Wockhardt Usa Inc. recalls Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90

Recalled July 29, 2015 · FDA recall D-1269-2015 · Wockhardt Usa

Hazard
CGMP Deviations: Firm did not adequately investigate customer complaints. · FDA Class II
Units
A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
Sold at
U.S. Nationwide including Puerto Rico.

Description

CGMP Deviations: Firm did not adequately investigate customer complaints.

Product
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.
Manufacturer(s)
Wockhardt Usa Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Wockhardt Usa Inc. recalls Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 | RecallWatchUSA