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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