Class II · Moderate risk
Brompheniramine Maleate
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.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL)
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
Betamethasone SP PF
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
Betamethasone SP
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
Betamethasone Combo PF 2 mL
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
Betamethasone Combo 10 mL
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
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 · 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.