Mylan Institutional, Inc. (d.b.a. UDL Laboratories): Drug Recall
Recall #D-0861-2022 · 04/01/2022
Class II: Risk
Recall Details
- Recall Number
- D-0861-2022
- 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
- 885 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 40 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 42292-010-16
Distribution Pattern
Nationwide within USA
Other Recalls by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Class II: Risk 04/01/2022
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.