Mylan Issues Recall of One Lot of Anti-Anxiety DrugBy
Mylan Pharmaceuticals is conducting a voluntary nationwide recall in the US of one lot of aprazolam tablets, USP C-IV 0.5 mg, to the consumer level due to the potential presence of foreign substance.
Mylan says the clinical impact from the foreign material, if present, is expected to be rare, but the remote risk of infection to a patient cannot be ruled out. To date (as of October 25, 2019), Mylan says it has not received any adverse events related to this batch.
Alprazolam tablets are indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety, and the treatment of panic disorder, with or without agoraphobia.
Alprazolam tablets, USP C-IV 0.5 mg, are packaged in bottles of 500. The batch was distributed in the US between July 2019 and August 2019. Mylan has notified its distributors and customers by letter and is arranging for the return of all recalled products. This recall is being conducted with the knowledge of the US Food and Drug administration.