Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park
Summary
The FDA issued a Class II for Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MA by Contract Pharmacal Corporation. Reason: Discoloration: Brownish tablets.
Details
Source
Drug Recall
External ID
D-0566-2024
Action Date
2024-07-03
Status
Ongoing
Category
drug
Product Description
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
Lot/Code Info: Lot#: 368638; Exp. 05/2025
Quantity Affected: 14,616 bottles
Reason for Recall
Discoloration: Brownish tablets
Distribution
MI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-20
Company
Hauppauge, NY
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 36 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Contract Pharmacal Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Contract Pharmacal Corporation have FDA actions?
This is the only FDA action we have on record for Contract Pharmacal Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0566-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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