D-1269-2015 Class II Terminated
FDA drug recall D-1269-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 29, 2015
- Initiation Date
- Apr 22, 2015
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
Product description
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.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution pattern
U.S. Nationwide including Puerto Rico.
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1269-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026