Yes — there is an active recall. 19 ongoing FDA recalls mention Phenyl (323 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenyl. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of Assurance of Sterility; product has the potential to leak.
Reason Lack of Assurance of Sterility; product has the potential to leak.
Reason Lack of Assurance of Sterility; product has the potential to leak.
Reason Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
Reason Lack of assurance of sterility: Product bags leaking at seam.
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason CGMP Deviations
Reason Lack of Sterility Assurance
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Reason Lack of Assurance of Sterility
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 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 CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Reason Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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