FDAFDA · Food and drugs·Recall number D-0825-2018
Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
Published May 30, 2018 · Recall initiated: April 24, 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
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Product was distributed throughout the United States, including Puerto Rico.
- Lot
- NDC 0378-7050-01 Lot Numbers: 3079386, Exp. 10/31/18 3079387, Exp. 10/31/18 3079388, Exp. 10/31/18 3083762, Exp. 3/31/19 3083763, Exp. 3/31/19 3083764, Exp. 3/31/19 3083765, Exp. 3/31/19 3083766, Exp. 3/31/19 3083767, Exp. 3/31/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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