Recall: D-1317-2020

Class II - Potentially Harmful

Class IIClassification

2020-05-11Initiated

TerminatedStatus

Torrent Pharma Inc.Firm

Product

Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd, Bharuch 392130, India; Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-268-05

Reason

Failed Dissolution Specifications

Distribution

USA Nationwide and Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.