Class II · Moderate risk
B1/B2/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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Class II · Moderate risk
B1/B2/B3/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow…
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Hydroxyprogesterone Caproate 250
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phentolamine 5 mg/mL in Normal Saline
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 500 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/20 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/2/20 Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 20/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 6/0.33/3.33 Injection Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 17/0.6/5.7 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 20 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phent .8/PGE1 20 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.