FDAFDA · Food and drugs·Recall number D-0857-2022
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
Published May 18, 2022 · Recall initiated: April 29, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUPROPION HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide in the USA
- UPC
- 0347335738865
- Lot
- Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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