Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3
Summary
The FDA issued a Class II for Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wil by Grato Holdings, Inc.. Reason: Microbial contamination of non-sterile product..
Details
Source
Drug Recall
External ID
D-0991-2022
Action Date
2022-06-15
Status
Terminated
Category
drug
Product Description
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Lot/Code Info: Lot #: G11639, Exp. Date 09/24
Quantity Affected: 31,872 bottles
Reason for Recall
Microbial contamination of non-sterile product.
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-24
Company
Woodbine, IA
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 180 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Grato Holdings, Inc. has 7 FDA actions in our database, including 7 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 (Grato Holdings, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Grato Holdings, Inc. have FDA actions?
Grato Holdings, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0991-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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