Guardian Drug Co. Inc. — Class II: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED
Guardian Drug Co. Inc. has initiated a Class II recall for HyVee Ultra Strength Antacid (Calcium Carbonate 1000 mg) due to the presence of foreign substances, specifically small metallic particles, in the chewable tablets.
This recall affects Guardian Drug Co. Inc. as the manufacturer, Hy-Vee Inc. as the distributor, and pharmaceutical quality and manufacturing professionals involved in solid oral dosage form production.
The presence of metallic particles in an oral tablet suggests a potential failure in the manufacturing or equipment maintenance process, such as equipment wear or inadequate screening. A Class II designation indicates that exposure may cause temporary or medically reversible adverse health consequences, necessitating a thorough investigation into the source of the contamination and a review of batch release procedures.
Quality teams should review metal detection protocols and foreign object prevention controls within the tableting and packaging lines. Regulatory and distribution teams must ensure all units associated with the affected UPC are accounted for and that the ongoing recall status is tracked to completion.
Class II. Reason: Presence of foreign substance: small metallic particles in chewable tablets.. Product: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5.. Firm: Guardian Drug Co. Inc. (Dayton NJ United States). Status: Ongoing.
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