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Defective Container: Confirmed customer complaints of leaking bottles.
Subpotent Drug
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Failed Impurities/Degradation Specifications
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Presence of particulate.
Healthy Mama Brand dietary supplements contain undeclared milk.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Lack of Assurance of Sterility; due to leaking vials
Failed Impurities/Degradation Specifications; 12 month stability testing.
Failed tablet specifications: One lot was found to contain oversized tablets.