The Recall Desk
ModerateFDA (Drugs)·D-172-2013·Announced 2013-03-06

Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

What this means for you

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, and the hazard involves a quality specification failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Amedra Pharmaceuticals LLC is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules. The product is prescription-only and was manufactured by Catalent Pharma Solutions for CorePharma, LLC. The specific lot affected is 220839, with an expiration date of 11/30/2013.

The recall was initiated because the affected lots may not meet the specifications for dissolution over the product shelf life. This means the medication may not release the active ingredient at the intended rate, potentially affecting its efficacy or safety profile.

The product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or credit.

The recalled product

Product
Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
Manufacturer
Amedra Pharmaceuticals LLC
Category
Drug — Prescription Medication
Hazard
Affected units
12,948

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 (2)

  • Lot 220839
  • exp 11/30/2013

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Amedra Pharmaceuticals 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 3 products in this recall →

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