Loxapine Capsules recalled over manufacturing violations

Recall date

May 1, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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. M…

Recall number

D-0822-2018

FDA classification

Class II

Brand / firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold / distributed

Nationwide in the U.S.

Why it was recalled

GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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