FDA-Drug2018-05-30Class II
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.
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
Sold states
Nationwide in the U.S.
Affected count
1,152 blister cards of 100 capsules each
Manufactured in
1718 Northrock Ct, N/A, Rockford, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0823-2018Don't want to check this manually?
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