Recalls / Class II
Class IID-0822-2018
Product
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
- Affected lot / code info
- Lot #: 3090454, Exp. 03/2019
Why it was recalled
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,065 blister cards of 100 capsules each
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2018-05-01
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-30
- Terminated
- 2021-03-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0822-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.