Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60
Summary
The FDA issued a Class III for Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Me by A-S Medication Solutions LLC.. Reason: Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tabl.
Details
Source
Drug Recall
External ID
D-0096-2022
Action Date
2021-11-17
Status
Terminated
Category
drug
Product Description
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
Lot/Code Info: Lot #: 1256330
Quantity Affected: 72 bottles
Reason for Recall
Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
Distribution
FL, IN, MN, WI
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-05
Company
Libertyville, IL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 163 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
A-S Medication Solutions LLC. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (A-S Medication Solutions LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does A-S Medication Solutions LLC. have FDA actions?
A-S Medication Solutions LLC. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0096-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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