Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 126 cartons of amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain multiple capsules.
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 agency classification is FDA Class II, and the hazard involves a controlled substance (CII) with a risk of significant injury due to potential overdose from mispackaging, meeting the criteria for a Severe rating.
Plain-English summary
Amerisource Health Services is recalling 126 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules, 15 mg. The affected products are identified by Lot 162489 (exp. 9/30/17) and Lot 162910 (exp. 10/31/17), with NDCs 68084-898-32 and 68084-898-33. The product was distributed nationwide.
The recall was initiated due to unit dose mispackaging, where blister cavities may contain more than one tablet or capsule. This packaging error poses a risk of medication overdose or incorrect dosing for patients using the product.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and returned to the distributor or manufacturer for credit. Consumers should consult their healthcare provider if they have concerns regarding their medication supply.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Controlled Substance
- Affected units
- 126
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 (3)
- Lot 162489
- exp. 9/30/17 and lot 162910
- exp. 10/31/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Amerisource Health Services 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.
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