Reported May 18, 2022 · Terminated
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86),…
Sun Pharmaceutical Industries Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- 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 bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
- Lot codes and dates
Lot #: a) JKX5126AJKX5127AJKX5128AExp 10/2022b) JKX5126BJKX5128BExp 10/2022c)JKX5126CJKX5127CJKX5128CExp 10/2022
- Amount recalled
- 9804 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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