Cefdinir for Oral Suspension USP, 250 mg/5 mL recall — FDA D-0518-2024
Defective container: lack of seal integrity.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Defective container: lack of seal integrity.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient
Out of Specification for active ingredient
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Out of Specification for active ingredient
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Lack of Assurance of Sterility.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Out of specification for assay
Discoloration: Dotted and yellow spots on tablets
Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
Discoloration: Dotted and yellow spots on tablets
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
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