58 FDA recalls mention Ketorolac. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ketorolac.
Reason Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Reason Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential…
Reason Lack of sterility assurance.
Reason Lack of Process Controls
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 Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been…
Reason Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
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 Crystallization; identified as calcium salt of Ketorolac
Reason Crystallization; identified as calcium salt of Ketorolac
Reason Crystallization
Reason Crystallization
Reason Crystallization
Reason Crystallization
Reason Crystallization
Reason Crystallization
Reason Presence of Particulate Matter: lot is not meeting the specification limit for number of particles present in the solution.
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