Class II · Moderate risk Terminated
Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion
Reason Lack of sterility assurance.
FDA Drug Recalls
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Class II · Moderate risk Terminated
Baclofen 2000mcg/Ml
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Alprostadil 40 mcg/mL
Reason Lack of sterility assurance.
Class III · Low risk Terminated
PCA Skin Blemish Control Bar
Reason Superpotent Drug: Salicylic acid content is above the firm's specification.
Class II · Moderate risk Terminated
Testosterone Topical Cream 4%
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Tadalafil 6 mg Capsule
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Tadalafil 20 mg Troche
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
T3/T4 SR 9 mcg/38 mcg capsule
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Squaric Acid 0.1% Topical Solution
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Sildenafil 80 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Sildenafil 200 mg Troche
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk Terminated
Progesterone E4M SR 100 mg capsules
Reason Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.