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: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
Reason Lack of sterility assurance.
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 Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or…
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.
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