Northern VA Compounders PLLC QuadMix Standard 002 recall — FDA D-0104-2023
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Lack of Assurance of Sterility
Lack of assurance of sterility: Bags have the potential to leak.
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Presence of foreign substance
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
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