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.

FDA recall notice · announced May 30, 2018 · Mylan Institutional, Inc. (d.b.a. Udl Laboratories)

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

The product

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.

Reason for recall

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

Notes

Distribution: Nationwide in the U.S.
Lot/code information: Lot #: 3092310, Exp. 03/2019
Quantity: 1,152 blister cards of 100 capsules each
Status: Terminated
Products in this recall event:
- 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 (D-0822-2018)
- 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. (D-0823-2018)

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