Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for F...
FDA Recall #D-0481-2022 — Class II — January 24, 2022
Product Description
Multi-Symptom Cramp Relief (acetaminophen 325mg and Pamabrom 25mg), 2- tablet packets, Mfd. for First Aid Direct, Mason, OH 45040
Reason for Recall
cGMP deviations
Recalling Firm
Ultra Seal Corporation — New Paltz, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,351,660 packets
Distribution
Nationwide within the United States
Code Information
Lot #: AK9453, Exp. Date 01/2022; AK9716, 07/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.