FDAFDA · Food and drugs·Recall number D-0823-2018
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.
Published May 30, 2018 · Recall initiated: May 1, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #: 3092310, Exp. 03/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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