Status
Terminated
Drug Enforcement D-172-2013
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Classification
Class II
Report Date
March 6, 2013
Termination Date
March 21, 2014
Product Information
- Product description
- Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
- Product quantity
- 12,948 bottles
- Reason for recall
- Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Amedra Pharmaceuticals LLC
- Address
-
2 Walnut Grove Dr, Suite 190
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-172-2013
- Event ID
- 63926
- Recall initiation date
- December 4, 2012
- Center classification date
- February 27, 2013
- Code info
- Lot 220839, exp 11/30/2013
- More code info
- —