Recalls / Class II
Class IID-1363-2014
Product
Pantoprazole Sodium, Delayed-release tablets, USP, 40 mg tablets, 100 (10x10) unit dose packages, Manufactured by Dr. Reddy's Laboratories Limited, India and Distributed by Major Pharmaceuticals, Livonia, MI --- NDC 0904-6235-61
- Affected lot / code info
- No lot or expiration date is displayed on this carton.
Why it was recalled
Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
Recalling firm
- Firm
- Legacy Pharmaceutical Packaging
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 13333 Lakefront Dr, N/A, Earth City, Missouri 63045-1514
Distribution
- Quantity
- unknown
- Distribution pattern
- IN
Timeline
- Recall initiated
- 2014-04-09
- FDA classified
- 2014-06-10
- Posted by FDA
- 2014-06-18
- Terminated
- 2017-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1363-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.