All Recalls

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Subpotent drug

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.