Actavis Recalls Amphetamine Tablets Due to Impurity Failures
Actavis is recalling specific lots of amphetamine tablets because they failed impurity specifications. Consumers should stop using the product and contact their pharmacist.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly when no specific hospitalization reports are cited but the classification implies significant risk.
Plain-English summary
Actavis Elizabeth LLC is recalling specific lots of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg. The recall involves 38,507 bottles distributed nationwide in the United States. The affected lots are 5245M141, 0953C151, 1728D151, and 3205G152.
The recall was initiated because the product failed impurities/degradation specifications, meaning it was out of specification for impurities. The FDA has classified this as a Class II recall, which indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients who have been prescribed these specific tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication. The product is prescription-only, so consumers should not attempt to dispose of or return the medication without consulting a professional.
The recalled product
- Product
- 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, Mo
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 38,507
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: 5245M141
- Expiry: 6/16
- Lot #: 0953C151
- Expiry date: 8/16Lot #: 1728D151
- Expiry: 9/16
- Lot #: 3205G152
- Expiry: 3/17.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Actavis Elizabeth LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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