Recalls / Class II
Class IID-0825-2018
Product
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
- Affected lot / code info
- NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19
Why it was recalled
CGMP Deviations
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
- 11,650 bottles
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
Timeline
- Recall initiated
- 2018-04-24
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-30
- Terminated
- 2019-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0825-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.