Dextroamphetamine Saccharate recall: Impurity Out of Spec
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 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: 45963-749-11.
Why was Dextroamphetamine Saccharate recalled?
Failed Impurities/Degradation Specifications: Out of specification for impurities.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1879E141, Expiry 02/16; Lot #: 1880E141, Expiry: 02/16; Lot #: 5034M142; Expiry: 5/16; Lot #: 0422A151, Expiry: 7/16; Lot #: 0423A151, Expiry: 7/16; Lot #: 1053C151, Expiry: 8/16; Lot #: 1054C151, Expiry: 8/16; Lot #: 2197E152, Expiry: 11/16; Lot #: 2198E151, Expiry: 12/16; Lot #: 2662F151, Expiry: 12/16; Lot #: 2672F152, Expiry: 3/17; Lot #: 3121G152, Expiry: 3/17; Lot #: 3798J151, Expiry: 4/17; Lot #: 5104M151, Expiry: 5/17.
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 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: 45963-749-11.
- Recalling firm
- Actavis Elizabeth LLC
- Quantity
- 182,378 Bottles
- Distribution
- US: Nationwide
- Recall date
- April 13, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)