Drug product
buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, carton barcode 6373945010.
D-002-2013
Product summary
- Event
- Event 63127
- Status
- Terminated
- Classification
- Class III
- Quantity
- 674 cartons
- Official record key
drug-enforcement:D-002-2013
Official wording
Reason: Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Code information: Lot #: 0075375, 0074584, Exp 08/12
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification