FDA recall D-0860-2022

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class II · drug

Product

Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16

Reason for recall

Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.

Distribution

Nationwide within USA

Key facts

Status: Terminated
Initiation date: 2022-04-01
Report date: 2022-05-18
Termination date: 2023-06-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Rockford, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0860-2022