Agency classClass IIOur severity:Severe FDA (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.

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 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: impurities
degradation
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 →

Same manufacturer · Impax Laboratories, Inc.

See all →

Severe
Impax Recalls Lamotrigine Tablets Due to Labeling Mixup
FDA (Drugs) · 2016-12-28
Severe
Impax Recalls Dextroamphetamine Sulfate Tablets Due to Failed Impurity Specifications
FDA (Drugs) · 2016-04-27
Low
Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20
Low
Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
FDA (Drugs) · 2016-04-20

Same hazard · impurities