PlainRecalls
FDA Drug Moderate Class II Terminated

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Reported: March 27, 2019 Initiated: January 18, 2019 #D-1013-2019

Product Description

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Reason for Recall

Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.

Details

Units Affected
10,281 UD cartons
Distribution
Nationwide USA and Puerto Rico
Location
Rockford, IL

Frequently Asked Questions

What product was recalled?
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 10,281 UD cartons.
Why was this product recalled?
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1013-2019.