Notice: Mylan Pharmaceuticals Recalls Alprazolam Tablets

Date: 11/06/19

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On October 25, 2019, the U.S. Food and Drug Administration (FDA) announced that Mylan Pharmaceuticals was recalling Alprazolam Tablets to the consumer level due to the potential presence of a foreign substance.

The FDA press release states the following:

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of a foreign substance. 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, Mylan 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. Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products.

Please immediately check your medical supplies, quarantine any drug products impacted and do not administer them. The identifying NDC and lot number associated with Mylan’s recalled product is: Alprazolam 0.5 mg Tablets (NDC 00378-4003-05, Lot 8082708).

Providers can review the FDA’s full press release here.