Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321…
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
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 - the firm is recalling select sterile drug products.
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
Reason Failed Dissolution Specifications; 6 month time point
Reason Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Reason CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Reason Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason Subpotent Drug: concentration of product is less than labeled amount.
Reason Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
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