Why it was recalled
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Product description
Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
Lot numbers, UPCs & expiration codes
Lot: 23132611, Exp 07/31/2026
Where it was sold
Nationwide in the USA
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-0541-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 16, 2024
- FDA report date
- Jun 12, 2024
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0541-2024, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94642
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot: 23132611, Exp 07/31/2026
- Postal code
- 08816-1149
- Report date
- Jun 12, 2024
- Product type
- Drugs
- Recall number
- D-0541-2024
- Classification
- Class III
- Recalling firm
- Rising Pharma Holding, Inc.
- Reason for recall
- Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 16, 2024
- Center classification date
- Jun 4, 2024