Guardian Drug Co. Inc. — Class II: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED
Guardian Drug Co. Inc. has initiated a Class II recall for HyVee Extra Strength Antacid (Calcium Carbonate 750 mg) chewable tablets due to the presence of small metallic particles. The recall is currently classified as ongoing.
This affects Guardian Drug Co. Inc., Hy-Vee Inc. distribution channels, and quality assurance personnel responsible for OTC drug manufacturing and foreign material control.
A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences. The presence of metallic particles suggests a potential breakdown in physical contaminant controls or equipment integrity during the manufacturing process, which may necessitate an investigation into preventive maintenance and filtration/detection systems.
QA/QC teams should review metal detection protocols and equipment maintenance logs for tablet compression and packaging lines. Regulatory teams should monitor for potential expansion of the recall to other batches or private-label brands produced at the same facility.
Class II. Reason: Presence of foreign substance: small metallic particles in chewable tablets.. Product: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1.. Firm: Guardian Drug Co. Inc. (Dayton NJ United States). Status: Ongoing.
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