D-001-2013 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
- 187 cartons
Product Description
buPROPion Hydrochloride Extended-Release Tablets (XL), 150 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 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910.
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 #: 0074583, Exp. Date 03/12