FDAFDA · Food and drugs·Recall number D-0816-2016
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 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: 45963-743-11.
Published April 13, 2016 · Recall initiated: February 16, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification for impurities.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Actavis Elizabeth LLC
- Distributor
- US: Nationwide
- Lot
- Lot #: 5245M141, Expiry: 6/16; Lot #: 0953C151, Expiry date: 8/16Lot #: 1728D151, Expiry: 9/16; Lot #: 3205G152, Expiry: 3/17.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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