Guardian Drug Co. Inc. — Class II: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Di
Guardian Drug Co. Inc. has initiated a Class II recall for CAREone Extra Strength Calcium Antacid chewable tablets due to the presence of small metallic particles.
This affects Guardian Drug Co. Inc. as the manufacturer, Foodhold U.S.A, LLC as the distributor, and quality/manufacturing professionals involved in OTC solid oral dosage form production.
The discovery of metallic particles suggests a potential failure in physical contaminant controls or equipment integrity during the manufacturing process. A Class II designation indicates that exposure may cause temporary or medically reversible adverse health consequences, necessitating a review of batch records and physical filtration/detection systems.
QA teams should review foreign material exclusion programs and maintenance logs for tablet presses or granulation equipment. Regulatory affairs should monitor the status of this ongoing recall to determine if additional lots or related private-label products are affected.
Class II. Reason: Presence of foreign substance: small metallic particles in chewable tablets.. Product: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80.. Firm: Guardian Drug Co. Inc. (Dayton NJ United States). Status: Ongoing.
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