Mylan Institutional, Inc. (d.b.a. UDL Laboratories): Drug Recall

Recall #D-0860-2022 · 04/01/2022

Class II: Risk

Recall Details

Recall Number: D-0860-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Status: Terminated
Date Initiated: 04/01/2022
Location: Rockford, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 555 cartons

Reason for Recall

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

Product Description

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

Distribution Pattern

Nationwide within USA

Other Recalls by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Class II: Risk 04/01/2022

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

View all recalls by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.