Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps
Summary
The FDA issued a Class II for Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dos by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Reason: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point..
Details
Source
Drug Recall
External ID
D-0860-2022
Action Date
2022-05-18
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot #: 3112743, Exp. Date 4/30/2023; 3112582, Exp. Date 3/31/2023; 3110438, 3111708, 3111120, Exp. Date 7/31/2022
Quantity Affected: 555 cartons
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mylan Institutional, Inc. (d.b.a. UDL Laboratories)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mylan Institutional, Inc. (d.b.a. UDL Laboratories) have FDA actions?
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0860-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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