Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

FDA recall notice · announced May 30, 2018 · Mylan Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01

Reason for recall

CGMP Deviations

Notes

Distribution: Product was distributed throughout the United States, including Puerto Rico.
Lot/code information: 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
Quantity: 11,650 bottles
Status: Terminated
Products in this recall event:
- Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 (D-0824-2018)
- Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 (D-0825-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.