FDA-Drug2019-03-27Class II

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

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard

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

Sold states
Nationwide USA and Puerto Rico
Affected count
10,281 UD cartons
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1013-2019

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