Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceutic
Summary
The FDA issued a Class II for Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Ma by Morton Grove Pharmaceuticals, Inc.. Reason: Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product..
Details
Source
Drug Recall
External ID
D-0713-2022
Action Date
2022-03-09
Status
Terminated
Category
drug
Product Description
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Lot/Code Info: Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Reason for Recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Distribution
Nationwide USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-21
Company
Morton Grove, IL
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 80 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Morton Grove Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 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 (Morton Grove Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Morton Grove Pharmaceuticals, Inc. have FDA actions?
Morton Grove Pharmaceuticals, Inc. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0713-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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