Lack of Assurance of Sterility
SCA Pharmaceuticals
Class I - Dangerous
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
cGMP deviations: due to shipment of rejected units.
Class I - Dangerous
Subpotent Drug: Out of specification results for low potency was obtained.
Subpotent Drug
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class I - Dangerous
Subpotent drug.
Class I - Dangerous
Subpotency: Out-of-specification stability test result for low potency was obtained.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I - Dangerous
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class I - Dangerous
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class I - Dangerous
Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
Class I - Dangerous
Lack of Assurance of Sterility.
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class I - Dangerous
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Lack Of Assurance Of Sterility.
Class I - Dangerous
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.