Class II · Moderate risk
Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and…
Lack of sterility assurance.
FDA Drug Recalls
906 recalls, newest first
Class II · Moderate risk
Memorial Central TPN. Rx Only
Lack of sterility assurance.
Class II · Moderate risk
Trimix 30mg/1 mg/10mcg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone Cyp/Pro 95/5%
Lack of Sterility Assurance.
Class II · Moderate risk
Testosterone 200 mg/mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 &6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 & 6
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 9 mg/6 mg vials
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West
Lack of Sterility Assurance.
Class II · Moderate risk
Sermorelin/Ipamorelin 18 mg/15 mg
Lack of Sterility Assurance.
Class II · Moderate risk
Nandrolone Decanoate 200 mg/mL Injectable
Lack of Sterility Assurance.
Class II · Moderate risk
Lipo MIC-12
Lack of Sterility Assurance.
Class II · Moderate risk
Ipamorelin Acetate 9 mg/9mL Injectable vials
Lack of Sterility Assurance.
Class II · Moderate risk
Human Chorionic Gonadotropin 12
Lack of Sterility Assurance.
Class II · Moderate risk
Human Chorionic Gonadotropin 5
Lack of Sterility Assurance.
Class II · Moderate risk
Human Chorionic Gonadotropin 10
Lack of Sterility Assurance.
Class II · Moderate risk
B-complex
Lack of Sterility Assurance.
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Sterility Assurance.
Class I · High risk
Amikacin Sulfate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class I · High risk
Prochlorperazine Edisylate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class II · Moderate risk
Bevacizumab 2.5 mg/0.1 mL
Lack of assurance of sterility
Class II · Moderate risk
Ketorolac Tromethamine Injection
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Class II · Moderate risk
Volumex (Iodinated I 131 Albumin)
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.