D-0825-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- April 24, 2018
- Termination Date
- August 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,650 bottles
Product Description
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Reason for Recall
CGMP Deviations
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Code Information
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