D-0861-2022 Class II Terminated
FDA drug recall D-0861-2022 was initiated by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) on April 1, 2022 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. The recall status is terminated (terminated June 9, 2023). Affected quantity: 885 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- May 18, 2022
- Initiation Date
- April 1, 2022
- Termination Date
- June 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 885 cartons
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
Reason for Recall
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Distribution Pattern
Nationwide within USA
Code Information
Lot #: 3110437, 3111409, 3110785, Exp. Date 7/31/2022; 3112173, Exp. Date 11/30/2022