D-0706-2017 Class II Terminated
FDA drug recall D-0706-2017 was initiated by Mylan Pharmaceuticals Inc. on Jun 22, 2016 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated Jul 12, 2017). Affected quantity: 24,176 bottles (1,450,560 tablets).
Recall details
- Product Type
- Drugs
- Report Date
- May 31, 2017
- Initiation Date
- Jun 22, 2016
- Termination Date
- Jul 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,176 bottles (1,450,560 tablets)
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
Distribution pattern
Nationwide
Code information
Code: 0378-5022-91 Lot: 3065878; Exp. 04/17
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0706-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026