Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
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
Acetylcysteine 10% Ophtalmic
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
All Products Intended to be Sterile
Lack of Assurance of Sterility
Class II · Moderate risk
Surgicept (Ethyl alcohol 70% w/w)
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Class II · Moderate risk
Fenoglide (fenofibrate)
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Class II · Moderate risk
Trimix Special
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL)
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
TRIMIX #3 (24 mg-1 mg-20 mcg/mL)
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL)
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
TRIMIX #1 Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Testosterone CYP/ENAN/PROP Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Testosterone Cypionate 50 mg/mL Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
sermorelin 1000 mcg/mL / LIDO 0.2% Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Sermorelin 1000 mcg/mL SUB-Q* Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Sermorelin 9 mg/10 mL SUB-Q* Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL)
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Progesterone 100 mg/mL Ethyl Oleate Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Progesterone 100 mg/mL in Corn Oil Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Progesterone 100 mg/mL IM* Injection in Sesame Oil
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
MIC Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Methylcobalamin 30 mg/mL PF Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Methylcobalamin 25 mg/mL PF Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.