Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packag
Summary
The FDA issued a Class III for Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 m by Ultra Seal Corporation. Reason: Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid..
Details
Source
Drug Recall
External ID
D-0075-2022
Action Date
2021-11-03
Status
Terminated
Category
drug
Product Description
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)
Lot/Code Info: Lot #: AK-9457, exp. date 22-Jan; AK-9521, exp. date 22-Mar; AK-9959, exp. date 22-Dec; AK-1017, exp. date 23-Jan
Quantity Affected: 991,310 tablets
Reason for Recall
Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-13
Company
New Paltz, NY
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 84 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ultra Seal Corporation has 64 FDA actions in our database, including 64 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 (Ultra Seal Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ultra Seal Corporation have FDA actions?
Ultra Seal Corporation has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0075-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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