FDA recall D-1285-2020

Teva Pharmaceuticals USA · Class II · drug

Product

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02

Reason for recall

Some bottles may contain mixed strengths of the product.

Distribution

Nationwide within the United State and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2020-05-22
Report date
2020-06-10
Termination date
2021-05-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1285-2020