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 CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Reason CGMP Deviations: potential for trace amounts of product carryover.
Reason Lack of assurance of sterility: Bags have the potential to leak.
Reason Failed Impurities/Degradation Specifications
Reason Lack of sterility assurance
Reason Lack of sterility assurance
Reason Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Presence of Particulate Matter: Glass particulate matter detected in injectable.
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Reason Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Reason Lack of sterility assurance: Bags have the potential to leak.
Reason Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Reason Failed Impurities/Degradation Specifications
Reason Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Reason CGMP Deviations:
Reason CGMP Deviations:
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