The Recall Desk
SevereFDA (Drugs)·D-0814-2016·Announced 2016-04-13

Actavis Recalls Dextroamphetamine Tablets Due to Impurity Failures

Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, because they failed impurity specifications.

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 are assigned a severity score of 4 (Severe), particularly when involving significant quality failures like impurity specifications in prescription drugs.

Plain-English summary

Actavis Elizabeth LLC is recalling 257,746 bottles of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. The product is manufactured by Actavis Elizabeth LLC and distributed by Actavis, Inc. The recall covers specific lots with expiration dates ranging from May 2016 to May 2017.

The recall was initiated because the tablets failed impurities/degradation specifications, specifically being out of specification for impurities. The FDA has classified this as a Class II recall, which indicates a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide in the United States. Patients and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. Consumers should not use the recalled product and should contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.

The recalled product

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 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, M
Manufacturer
Actavis Elizabeth LLC
Category
Drug — Prescription Medication
Hazard
Affected units
257,746

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 #: 3992J141
  • Expiry: 5/16
  • Lot #: 3993J142
  • Lot #: 0695B151
  • Expiry: 7/16
  • Lot #: 0696B151
  • Lot #: 0378A151
  • Lot #: 0379A151
  • Lot #: 0697B151
  • Expiry: 8/16
  • Lot #: 2427F151
  • Expiry: 11/16
  • Lot #: 1947E151
  • Lot #: 1330C151
  • Lot #: 1331C151
  • Lot #: 1946E151
  • Lot #: 3652H151
  • Expiry: 2/17
  • Lot #: 3653H151
  • 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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Same hazard · impurities

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