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.
Reported: May 30, 2018 Initiated: May 1, 2018 #D-0823-2018
Product Description
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
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 1,152 blister cards of 100 capsules each
- Distribution
- Nationwide in the U.S.
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 1,152 blister cards of 100 capsules each.
Why was this product recalled? ▼
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0823-2018.
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