D-0825-2018 Class II Terminated
FDA drug recall D-0825-2018 was initiated by Mylan Pharmaceuticals Inc. on Apr 24, 2018 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Aug 14, 2019). Affected quantity: 11,650 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- Apr 24, 2018
- Termination Date
- Aug 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0825-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026