Recalls / Class II
Class IID-0825-2016
Product
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
- Affected lot / code info
- Lot # 112579, 112580, Exp 03/17; 111013A, Exp 04/16; 111014, Exp 05/16; 113292, 113332, 113386, 113387, Exp 07/17; 111671,111673, Exp 09/16; 113806, 113807, Exp 10/17; 111874, 111875, 111876, Exp 11/16
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
- 67,428 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-0825-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.