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.
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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
Class II · Moderate risk
Estradiol 10mg pellet
Lack of Assurance of Sterility