Recalls / Class II
Class IID-0186-2020
Product
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
- Affected lot / code info
- Lot #: 8082708, Exp. Date September 2020
Why it was recalled
Presence of Foreign Substance
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 5,760 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-10-23
- FDA classified
- 2019-11-05
- Posted by FDA
- 2019-11-13
- Terminated
- 2020-12-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0186-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.