Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors
Amerisource Health Services is recalling 2,276 cartons of 10 mg amphetamine tablets because blister cavities may contain more than one tablet.
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 agency classification is FDA Class II, and the hazard involves a controlled substance (Schedule II) where mispackaging can lead to significant injury or overdose.
Plain-English summary
Amerisource Health Services is recalling 2,276 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg. The affected product is packaged and distributed by American Health Packaging, Columbus, OH, and is identified by NDC 68084-936-25 (Carton) and NDC 68084-936-95 (Blister). The recall covers Lot 150130 (exp. 10/31/16) and Lot 161296 (exp. 8/31/17).
The recall was initiated due to unit dose mispackaging, where blister cavities may contain more than one tablet. This defect poses a risk of medication overdose if the product is administered as intended. The product was distributed nationwide.
Healthcare providers and pharmacies should stop using the affected product and contact Amerisource Health Services for instructions on returning or disposing of the stock. Patients should consult their healthcare provider if they have received or used the affected medication.
The recalled product
- Product
- Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 2,276
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 150130
- exp. 10/31/16 and lot 161296
- exp. 8/31/17
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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