Recall: D-1345-2015

Class III - Minor Violations

Class IIIClassification

2015-07-17Initiated

TerminatedStatus

Sun Pharma Global FzeFirm

Product

buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86

Reason

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

Distribution

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.