Recall: D-0044-2024

Class III - Minor Violations

Class IIIClassification

2023-10-04Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

Product

Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, 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, NDC 47335-737-86

Reason

Failed Dissolution Specifications

Distribution

Nationwide in the USA.

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