Reported May 18, 2022 · Terminated
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6…
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · 1718 Northrock Ct · Rockford, IL · 61103-1201
Is this the product you have?
- 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 forMylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
- Lot codes and dates
Lot #: 3112743Exp. Date 4/30/20233112582Exp. Date 3/31/2023311043831117083111120Exp. Date 7/31/2022
- Amount recalled
- 555 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
This product could cause temporary or reversible health problems — stop using it.
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