PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796…
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
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: Leaking/damaged syringes.
Reason Lack of Assurance of Sterility: Leaking/damaged syringes.
Reason Presence of Particulate Matter
Reason LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum…
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason Presence of Foreign Tablets/Capsules.
Reason Presence of Particulate Matter
Reason Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride…
Reason Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10…
Reason Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port.
Reason Lack of Assurance of Sterility
Reason Failed Dissolution Specifications.
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
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