Class II · Moderate risk
Phenylephrine 30 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
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 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
Class II · Moderate risk
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme…
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Class II · Moderate risk
Cidofovir injection 375 mg/mL
Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Class II · Moderate risk
HydrOXYzine HYDROCHLORIDE SYRUP
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk
Diet Power
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.