Class II · Moderate risk
Nandrolone Decanoate 200 mg/mL Injectable
Lack of Sterility Assurance.
FDA Drug Recalls
11,818 recalls · Class II, newest first
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 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).
Class II · Moderate risk
Hydrocortisone Acetate Suppositories
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Memantine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Memantine Hydrochloride Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Lactulose Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Lactulose Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Nasal Decongestant Liquid
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Diphenhist Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).