D-0186-2020 Class II Terminated
FDA drug recall D-0186-2020 was initiated by Mylan Pharmaceuticals Inc. on Oct 23, 2019 and is designated Class II. Reason for recall: Presence of Foreign Substance The recall status is terminated (terminated Dec 10, 2020). Affected quantity: 5,760 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 23, 2019
- Termination Date
- Dec 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,760 bottles
Product description
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05
Reason for recall
Presence of Foreign Substance
Distribution pattern
Nationwide within the United States
Code information
Lot #: 8082708, Exp. Date September 2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0186-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026