Allergan Voluntarily Recalls Nearly 600,000 Bottles of Generic Drug
Allergan is voluntarily recalling 593,019 bottles impacting 48 lots in four dosage forms of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets, a generic version of Adderall, a drug to treat attention deficit hyperactivity disorder, due to failed impurities/degradation specifications that gave rise to out-of-specification results for impurities. The Class II recall was initiated in the US, including Puerto Rico, on February 16, 2016 and is ongoing. It was reported in the US Food and Drug Administration Weekly Enforcement Report of April 13, 2016.
A Class II recall 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. The recall was initiated by Actavis Elizabeth LLC, part of Allergan, in Elizabeth, New Jersey.
The recall applies as follows: (1) 182,378 of 30-mg, 100-count. bottles, prescription only; (2) 114,388 of 10-mg, 100- count. bottles, prescription only; (3) 257,746 of 20-mg, 100 count bottles, prescription only; and 38,507 5-mg, 100 count bottles, prescription only.
Source: US Food and Drug Administration