Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Recalled May 30, 2018 · FDA recall D-0822-2018 · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination · FDA Class II
Units
1,065 blister cards of 100 capsules each
Sold at
Nationwide in the U.S.
Description
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Product
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
Manufacturer(s)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →