0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC…
Reason Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Reason Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the…
Reason Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Reason Subpotent Drug; out of specification results for heparin raw material
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
Reason Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…
Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…
Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
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