Status
Terminated
Drug Enforcement D-190-2013
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Classification
Class III
Report Date
March 13, 2013
Termination Date
March 6, 2014
Product Information
- Product description
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11.
- Product quantity
- 9,264 Bottles
- Reason for recall
- Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Actavis Elizabeth LLC
- Address
-
200 Elmora Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-190-2013
- Event ID
- 64506
- Recall initiation date
- February 13, 2013
- Center classification date
- March 7, 2013
- Code info
- Lot #: 50077231
- More code info
- —