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

FDA recall notice · announced March 27, 2019 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide USA and Puerto Rico
Lot/code information: Lots: 3095198, 3096266, 3098776, EXP 05-2019
Quantity: 10,281 UD cartons
Status: Terminated
Products in this recall event:
- Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20 (D-1013-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.