SUN PHARMACEUTICAL INDUSTRIES INC: Drug Recall

Recall #D-0857-2022 · 04/29/2022

Class III: Low Risk

Recall Details

Recall Number
D-0857-2022
Classification
Class III
Product Type
Drug
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Status
Terminated
Date Initiated
04/29/2022
Location
Princeton, NJ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9804 bottles

Reason for Recall

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.

Product Description

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), 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

Distribution Pattern

Nationwide in the USA

Other Recalls by SUN PHARMACEUTICAL INDUSTRIES INC

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.