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
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- 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.
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