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Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Undeclared fish and soy.
Undeclared milk
Lack of assurance of sterility.
Lack of Assurance of Sterility: Malformed crimped collar seal
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
CGMP deviation: product outside labeled storage temperature requirements.
Colostrum is declared but label does not declare milk.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.