Recalls / Class II
Class IID-0813-2016
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.
- Affected lot / code info
- Lot #: 2172#141, Expiry: 3/16; Lot #: 4217K141, Expiry: 3/16; Lot #: 0420A151, Expiry: 7/16; Lot #: 0421A151, Expiry: 7/16; Lot #: 0854B151, Expiry: 10/16; Lot #: 1329C151, Expiry: 10/16; Lot #: 2692F151, Expiry; 2/17; Lot #: 3202G151, Expiry: 3/17; Lot #: 3796J151, Expiry: 3/17; Lot #: 3797J151, Expiry: 4/17.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Recalling firm
- Firm
- Actavis Elizabeth LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 200 Elmora Ave, N/A, Elizabeth, New Jersey 07202-1106
Distribution
- Quantity
- 114,388 Bottles
- Distribution pattern
- US: Nationwide
Timeline
- Recall initiated
- 2016-02-16
- FDA classified
- 2016-04-07
- Posted by FDA
- 2016-04-13
- Terminated
- 2017-09-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0813-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.