Guardian Drug Co. Inc. — Class II: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle,
Guardian Drug Co. Inc. has initiated a Class II recall for Haleon Calcium Carbonate Tums Antacid (1000 mg, 160-count bottles) due to the presence of small metallic particles in the chewable tablets. The recall is currently listed as ongoing.
This recall affects the contract manufacturer (Guardian Drug Co. Inc.), the brand owner (Haleon), and professionals in quality control, manufacturing, and distribution of OTC antacid products.
The presence of foreign metallic substances suggests a potential failure in the manufacturing process or equipment integrity, such as metal-on-metal wear or screen breakage. While classified as Class II (suggesting a lower risk of permanent health consequences), the incident likely requires a thorough CAPA (Corrective and Preventive Action) investigation to identify the source of contamination and assess the effectiveness of in-line metal detection or physical screening protocols.
QA teams should review manufacturing logbooks for equipment wear or maintenance issues that could result in metal shedding. Supply chain and distribution departments should immediately verify inventory against the specified UPC (3 07660 74610 2) to ensure affected lots are quarantined.
Class II. Reason: Presence of foreign substance: small metallic particles in chewable tablets.. Product: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.. Firm: Guardian Drug Co. Inc. (Dayton NJ United States). Status: Ongoing.
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