The Recall Desk
HighFDA (Drugs)·D-1483-2016·Announced 2016-09-14

Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

Amerisource Health Services is recalling 1,416 cartons of 15 mg amphetamine tablets because blister cavities may contain more than one tablet.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (overdose) from a controlled substance due to mispackaging, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Amerisource Health Services is recalling 1,416 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg. The product is packaged as 30 unit-dose tablets (5 x 6) and is distributed by American Health Packaging in Columbus, Ohio. The recall involves Lot 150950 (exp. 3/31/17) and Lot 154813 (exp. 5/31/2017).

The recall was initiated because of unit dose mispackaging, where blister cavities may contain more than one tablet. This defect poses a risk of medication overdose if a patient or caregiver administers the contents of a single blister cavity without verifying the tablet count.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs (60687-133-25 for cartons and 60687-133-95 for blisters) and lot numbers listed above. If the product is found, it should be quarantined and returned to the distributor or disposed of according to local regulations.

The recalled product

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 15 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
Affected units
1,416

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 150950
  • exp. 3/31/17 and lot 154813
  • exp. 5/31/2017

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.

See all 10 products in this recall →