PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: June 12, 2024 Initiated: May 16, 2024 #D-0541-2024

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

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.

Details

Units Affected
N/A
Distribution
Nationwide in the USA
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Rising Pharma Holding, Inc.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 12, 2024. Severity: Low. Recall number: D-0541-2024.