Recalls / Class II
Class IID-1269-2015
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.
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
Recalling firm
- Firm
- Wockhardt Usa Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271
Distribution
- Quantity
- A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-04-22
- FDA classified
- 2015-07-17
- Posted by FDA
- 2015-07-29
- Terminated
- 2018-05-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1269-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.