Drug product
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count 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 47335-738-86
D-0858-2022
Product summary
- Event
- Event 90088
- Status
- Terminated
- Classification
- Class III
- Quantity
- 744 bottles
- Official record key
drug-enforcement:D-0858-2022
Official wording
Reason: 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.
Code information: Lot #: HAC2237A, exp. date 05/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance