Class II · Moderate risk
Sermorelin/GHRP-2 & 6
Lack of Sterility Assurance.
FDA Drug Recalls
1,563 recalls, newest first
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 II · Moderate risk
Cefdinir for Oral Suspension USP
Complaint received of metal piece identified in the product bottle prior to the reconstitution.
Class III · Low risk
Ondansetron Injection
Failed Impurities/Degradation Specifications.
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
Bisacodyl Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
RisperiDONE Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Anu-Med brand of Hemorrhoidal Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Hemorrhoidal Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Laxative Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).