The Recall Desk
SevereFDA (Drugs)·D-0825-2016·Announced 2016-04-27

Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications

Impax Laboratories is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, because the product failed impurities and degradation 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score per the rubric, as it involves a product that may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Impax Laboratories, Inc. is recalling 67,428 bottles of Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottles. The product is prescription-only and was manufactured and distributed by Corepharma, LLC. The recall is being conducted because the product failed impurities and degradation specifications.

The affected product is identified by NDC 64720-0216-10. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 112579, 112580, 111013A, 111014, 113292, 113332, 113386, 113387, 111671, 111673, 113806, 113807, 111874, 111875, and 111876. The product was distributed nationwide.

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

The recalled product

Product
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Manufacturer
Impax Laboratories, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
67,428

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 # 112579
  • 112580
  • Exp 03/17
  • 111013A
  • Exp 04/16
  • 111014
  • Exp 05/16
  • 113292
  • 113332
  • 113386
  • 113387
  • Exp 07/17
  • 111671
  • 111673
  • Exp 09/16
  • 113806
  • 113807
  • Exp 10/17
  • 111874
  • 111875

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Impax Laboratories, Inc. 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 2 products in this recall →

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