Class II
Terminated
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
- Recall Initiated
- April 1, 2022
- Posted
- May 18, 2022
- Recall Number
- D-0860-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 555 cartons
- Firm Location
- Rockford, IL, United States
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
Lot / Code Info
Lot #: 3112743, Exp. Date 4/30/2023; 3112582, Exp. Date 3/31/2023; 3110438, 3111708, 3111120, Exp. Date 7/31/2022
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