FDAFDA · Food and drugs·Recall number D-0860-2022
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
Published May 18, 2022 · Recall initiated: April 1, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide within USA
- Lot
- Lot #: 3112743, Exp. Date 4/30/2023; 3112582, Exp. Date 3/31/2023; 3110438, 3111708, 3111120, Exp. Date 7/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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