Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
National Drug Code
Bupropion hydrochloride · 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-737-13)
2 FDA recalls name the code 47335-0737-13 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
Failed Dissolution Specifications
Failed Dissolution Specifications; during stability testing
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.
Failed Dissolution Specifications; 18 month stability time point
Failed Dissolution Specifications
Failed Dissolution Specifications
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
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