The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0815-2016·Announced 2016-04-13

Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

Actavis Elizabeth LLC is recalling 182,378 bottles of 30 mg Dextroamphetamine and Amphetamine tablets because they failed impurity specifications.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses, injuries, or fatalities, and the hazard is a failure of impurity specifications rather than a known high-risk pathogen or structural defect.

Plain-English summary

Actavis Elizabeth LLC is recalling 182,378 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. The recall is being conducted because the product failed impurities/degradation specifications, specifically being out of specification for impurities.

The affected product is prescription-only and was distributed nationwide in the United States. The recall covers 14 specific lot numbers with expiry dates ranging from February 2016 to May 2017. The product was manufactured by Actavis Elizabeth LLC and distributed by Actavis, Inc.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiry dates listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for credit or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

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…
Manufacturer
Actavis Elizabeth LLC
Category
Drug — Prescription Medication
Hazard
Affected units
182,378

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 (20)

  • Lot #: 1879E141
  • Expiry 02/16
  • Lot #: 1880E141
  • Expiry: 02/16
  • Lot #: 5034M142
  • Expiry: 5/16
  • Lot #: 0422A151
  • Expiry: 7/16
  • Lot #: 0423A151
  • Lot #: 1053C151
  • Expiry: 8/16
  • Lot #: 1054C151
  • Lot #: 2197E152
  • Expiry: 11/16
  • Lot #: 2198E151
  • Expiry: 12/16
  • Lot #: 2662F151
  • Lot #: 2672F152
  • Expiry: 3/17
  • Lot #: 3121G152

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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