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Unapproved Drug Claims.
Unapproved Drug Claims and Misbranded.
Presence of foreign substance: identified as aluminum.
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Potential for spoilage due to yeast contamination.
Lack of Assurance of Sterility.
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Subpotent drug
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Undeclared milk from Contains statement.