Drug 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.
D-1269-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
- Official record key
drug-enforcement:D-1269-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: A) Lot #: LN10933, Expiry: 4/30/2015; Lot #: LN10935, Expiry: 4/30/2015; Lot #: LN11063, Expiry: 4/30/2015. B) Lot #: LN10987, Expiry: 4/30/2015; Lot #: LN11415, Expiry: 6/30/2015. C) Lot #: LN10986, Expiry: 4/30/2015; Lot #: LN11414, Expiry: 6/30/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations