Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium PHOSphate added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium CHLORide added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Potassium CHLORide added to 0.9% Sodium Chloride
Reason Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Class III · Low risk Terminated
Risedronate Sodium Delayed-release Tablets
Reason Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.
Class III · Low risk Terminated
Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9%…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
Zenatane
Reason Failed dissolution specifications - low dissolution results at S3 stage.
Class III · Low risk Terminated
PreviDent 5000 ppm
Reason Label Mix up; rear panel is incorrectly labeled with the PreviDent 5000 Enamel Protect rear panel.
Class III · Low risk Terminated
Salicylic Acid Cream
Reason Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk Terminated
Salicylic Acid Shampoo
Reason Failed Impurities/Degradation Specifications: The API for these products had an out of specification result for an organic impurity.
Class III · Low risk Terminated
Levofloxacin Ophthalmic Solution
Reason Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at the 18 month stability time point.
Class III · Low risk Terminated
Q Care Continue Care Kit for the non-ventilated patient
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Care kit is printed with an expiration date of November 13, 2017; rather than the correct date of August 28, 2017 (date of expiration of the Corinz Antiseptic Cleansing & Moisturizing Oral Rinse). Note, the correct expiration date of August 28, 2017, is printed on the Corinz Oral Rinse package.
Class III · Low risk Terminated
Norethindrone Acetate and Ethinyl Estradiol Tablets
Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk Terminated
Tarina Fe 1/20
Reason Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class III · Low risk Terminated
Buffered Lidocaine
Reason Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%