Drug recall: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
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Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan — Eugia US LLC · Class III · Ongoing · 168,300 vials
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications — Ascend Laboratories, LLC · Class II · Ongoing · 15,696 x 30's bottles
CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. — Asclemed USA Inc. · Class II · Ongoing · 50 bottles
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Presence of foreign substance: small metallic particles in chewable tablets. — Guardian Drug Co. Inc. · Class II · Ongoing
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint. — Lannett Company Inc. · Class II · Ongoing · 3984 bottles