Mylan Pharmaceuticals Inc. is carrying out a voluntary nationwide recall of one lot of Alprazolam tablets, USP C-IV 0.5 mg, due to the potential presence of a foreign substance.
At present, Mylan has not received any adverse events and clinical impact from the foreign material, if present, is expected to be rare. However, the remote risk of infection to a patient cannot be ruled out.
Alprazolam tablets, indicated for the management of anxiety disorder, are packaged in bottles of 500. This particular lot was distributed in the U.S. between July 2019 and August 2019.
| NDC | Product Description and Strength | Size | Lot number | Expiry |
| 0378-4003-05 | Alprazolam Tablets, USP C-IV 0.5 mg | Bottles of 500 | 8082708 | September 2020 |
Wholesalers are advised to immediately examine their inventory, quarantine and discontinue distribution of these lots. If the product has been distributed, they are requested to identify the retail-level customers and provide a list of customers via Microsoft excel file to mylan5924@stericycle.com within 10 business days. Stericycle will notify your retail-level customers that they received the affected batches.
Retailers are also advised to do the same with their inventory and to identify the consumer and notify them immediately of this product recall if the product has been further distributed. The consumer should be instructed to contact Stericycle at 1-888-843-0255 for the documentation packet to return the product.
For further questions, consumers can also contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or health care provider in case they have experienced any problems that are possibly related to using this drug product.
