Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Reported: May 31, 2017 Initiated: June 22, 2016 #D-0706-2017
Product Description
Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Reason for Recall
Failed Dissolution Specifications
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 24,176 bottles (1,450,560 tablets)
- Distribution
- Nationwide
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 24,176 bottles (1,450,560 tablets).
Why was this product recalled? ▼
Failed Dissolution Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 31, 2017. Severity: Moderate. Recall number: D-0706-2017.
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