Class II · Moderate risk Terminated
Trimix 30mg/1 mg/10mcg/mL
Reason Lack of Sterility Assurance.
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Class II · Moderate risk Terminated
Testosterone Cypionate 200 mg/mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Testosterone Cyp/Pro 95/5%
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Testosterone 200 mg/mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 &6
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 &6
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 & 6
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 9 mg/6 mg vials
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 9 mg/9 mg vials Pharm D. Solutions 1304 South Loop West
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/Ipamorelin 18 mg/15 mg
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Nandrolone Decanoate 200 mg/mL Injectable
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Lipo MIC-12
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Ipamorelin Acetate 9 mg/9mL Injectable vials
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 12
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 5
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 10
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
B-complex
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Bacteriostatic Water for Injection
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Cefdinir for Oral Suspension USP
Reason Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Class III · Low risk Terminated
Ondansetron Injection
Reason Failed Impurities/Degradation Specifications.
Class I · High risk Terminated
Amikacin Sulfate Injection
Reason 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 Terminated
Prochlorperazine Edisylate Injection
Reason 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 Terminated
Bisacodyl Suppositories
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk Terminated
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
Reason cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).