Recalls / Class II
Class IID-0826-2016
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
- Affected lot / code info
- Lot #: 112565, Exp 03/17; 113458, Exp 08/17
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Impax Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 215 Wood Ave, N/A, Middlesex, New Jersey 08846-2554
Distribution
- Quantity
- 18,936 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-14
- FDA classified
- 2016-04-21
- Posted by FDA
- 2016-04-27
- Terminated
- 2018-02-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0826-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.