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
Product description
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
Lot numbers, UPCs & expiration codes
No lot or expiration date is displayed on this carton.
Where it was sold
IN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1363-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 9, 2014
- FDA report date
- Jun 18, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Legacy Pharmaceutical Packaging
Original FDA data
Every field from FDA enforcement report D-1363-2014, exactly as published.
Show all FDA fields
- City
- Earth City
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 67978
- Address
- 13333 Lakefront Dr
- Code information
- No lot or expiration date is displayed on this carton.
- Postal code
- 63045-1514
- Report date
- Jun 18, 2014
- Product type
- Drugs
- Recall number
- D-1363-2014
- Classification
- Class II
- Recalling firm
- Legacy Pharmaceutical Packaging
- Product quantity
- unknown
- Termination date
- Jan 6, 2017
- Reason for recall
- Correct Labeled Product Miscart/Mispack: some cartons labeled as Pantoprazole Sodium Delayed-Release may contain correctly labeled blister cards of Lorazepam tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- IN
- Recall initiation date
- Apr 9, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 10, 2014