Class II · Moderate risk
Catapres .2
Failed Dissolution Specifications: OOS resultsduring routine stability testing
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
children's allergy relief
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
children's allergy
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
Children's 24 Hour Allergy
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
Phenylephrine 30 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Phenylephrine 25 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Hydromorphone
Lack of assurance of sterility
Class II · Moderate risk
Fentanyl (10 mcg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Morphine (1 mg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Metoprolol Succinate Extended Release Tablets
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class II · Moderate risk
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class III · Low risk
Prednisolone and Gatifloxacin Ophthalmic Solution
Presence of precipitate
Class II · Moderate risk
Testosterone 200 mg/Anastrozole 20 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 87.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 50mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 37.5 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 25 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 200mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 12.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 100mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 6 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 25mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 18mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 15mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Estradiol 12.5mg pellet
Lack of Assurance of Sterility