Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HD
Summary
The FDA issued a Class III for Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Rel by Granules Consumer Health Inc.. Reason: Label mix-up: Carton incorrectly labeled..
Details
Source
Drug Recall
External ID
D-0627-2024
Action Date
2024-08-14
Status
Terminated
Category
drug
Product Description
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India
Lot/Code Info: Lot #: 31670346AA, Exp 12/31/2026
Quantity Affected: 21,192 Bottles
Reason for Recall
Label mix-up: Carton incorrectly labeled.
Distribution
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-18
Company
Manassas, VA
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Granules Consumer Health Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Granules Consumer Health Inc. have FDA actions?
This is the only FDA action we have on record for Granules Consumer Health Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0627-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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