D-002-2013 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 10, 2012
- Initiation Date
- March 29, 2012
- Termination Date
- April 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 674 cartons
Product Description
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.
Reason for Recall
Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.
Distribution Pattern
Nationwide
Code Information
Lot #: 0075375, 0074584, Exp 08/12