The Recall Desk
ModerateFDA (Drugs)·D-1481-2016·Announced 2016-09-14

Amerisource Recalls Mispackaged Dextroamphetamine and Amphetamine Tablets

Amerisource Health Services is recalling 221 cartons of mixed amphetamine tablets due to unit dose mispackaging, where blister cavities may contain more than one tablet.

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 unit dose mispackaging which is a low-risk contamination or labeling error without reported injuries.

Plain-English summary

Amerisource Health Services is recalling 221 cartons of Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg. The product is packaged and distributed by American Health Packaging in Columbus, Ohio, and was distributed nationwide.

The recall is being conducted because of unit dose mispackaging, where blister cavities may contain more than one tablet. The affected lots are 163220 (exp. 10/31/17) and 164194 (exp. 11/20/17). The product is identified by Carton NDC 68084-874-25 and Blister NDC 68084-874-95.

Healthcare providers and patients should check their inventory for these specific lot numbers and NDC codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer.

The recalled product

Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
Affected units
221

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 163220
  • exp. 10/31/17 and lot 164194
  • exp. 11/20/17

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.

See all 10 products in this recall →