Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation…
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
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 Presence of Particulate Matter: particulate matter identified as fibers and/or plastics
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Reason Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Reason Lack of Assurance of Sterility: Firm received fentanyl from a supplier who recalled it because fliptop vial crimps were loose or missing.
Reason Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Reason Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Reason Non Sterility; microbial contamination identified as Aspergillus species
Reason Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Reason Subpotent Drug.
Reason Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Reason Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.
Reason Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Reason Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Reason Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Reason Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Reason Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
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