Recall: D-0085-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-01Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Reason

Presence of foreign substance

Distribution

Nationwide within the United States

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