Recalls / Class III
Class IIID-0541-2024
Product
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
- Brand name
- Pregabalin
- Generic name
- Pregabalin
- Active ingredient
- Pregabalin
- Route
- Oral
- NDCs
- 64980-410, 64980-411, 64980-412, 64980-413, 64980-414, 64980-415, 64980-416, 64980-417
- FDA application
- ANDA210432
- Affected lot / code info
- Lot: 23132611, Exp 07/31/2026
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.
Recalling firm
- Firm
- Rising Pharma Holding, Inc.
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1401, N/A, East Brunswick, New Jersey 08816-1149
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-05-16
- FDA classified
- 2024-06-04
- Posted by FDA
- 2024-06-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0541-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.