D-0823-2018 Class II Terminated
FDA drug recall D-0823-2018 was initiated by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) on May 1, 2018 and is designated Class II. Reason for recall: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination The recall status is terminated (terminated March 10, 2021). Affected quantity: 1,152 blister cards of 100 capsules each.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- May 1, 2018
- Termination Date
- March 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,152 blister cards of 100 capsules each
Product Description
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
Reason for Recall
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #: 3092310, Exp. 03/2019