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: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Reason Lack of Assurance of Sterility
Reason Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Reason Lack of Sterility Assurance.
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Reason Sub-potency
Reason CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
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