The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0816-2016·Announced 2016-04-13

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
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.

See all 4 products in this recall →

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