FDA recall D-0826-2016
Impax Laboratories, Inc. · Class II · drug
Product
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Reason for recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2016-03-14
- Report date
- 2016-04-27
- Termination date
- 2018-02-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Middlesex, NJ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0826-2016