Class II · Moderate risk
Biest Td 50/50
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
Biest Cp 80/20
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest Cp 80/20
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest Cp 76/24: Dhea
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest 80/20 : Progest : Dhea : Testost
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Biest 66/34: Testosterone : Progesterone in Olive Oil
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Class II · Moderate risk
Fomepizole Injection
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
Class I · High risk
Magnesium Sulfate in 5% Dextrose Injection
Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
Class II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Class II · Moderate risk
5% DEXTROSE Injection
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Class II · Moderate risk
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters
Failed dissolution specifications
Class II · Moderate risk
Haloperidol Oral Solution
Defective Container: Confirmed customer complaints of leaking bottles.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Failed Stability Specifications: Out of specification for preservative, benazalkonium chloride.
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class III · Low risk
Quinapril Tablets USP
Subpotent Drug
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class III · Low risk
Oxecta (oxycodone HCl)
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Minivelle (estradiol transdermal system)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class II · Moderate risk
RIFAMPIN for Injection
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Colistimethate for Injection USP
Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
Class II · Moderate risk
Droperidol injection
Presence of particulate.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.
Class II · Moderate risk
Atracurium Besylate Injection
Lack of Assurance of Sterility: Recall initiated due to FDA observations pertaining to aseptic and GMP practices at the manufacturers site potentially impacting product sterility.