292 FDA recalls mention Phenylephrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenylephrine.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Reason Lack Of Assurance Of Sterility.
Reason Superpotent Drug
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason Lack of Assurance of Sterility.
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
Reason Lack of Sterility Assurance.
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 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 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: 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
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