Class II · Moderate risk
Adult Glycerin Suppositories
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
FDA Drug Recalls
103 recalls, newest first
Class II · Moderate risk
Adult Glycerin Suppositories
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Adult Glycerin Suppositories
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Children Glycerin Suppositories Laxative for ages 2 to 5. Package…
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
CVS Therapeutic Menthol Gel
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
CVS Health Glycerin Suppositories
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
Class II · Moderate risk
Diphenhydramine HCL Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Acetaminophen Children's Liquid
Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen DM
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cetirizine HCL Oral Solution 1 mg/mL
cGMP Deviations: Firm was notified by their supplier of Cetirizine HCL Oral Solution, USP, 1mg/mL, 4oz, of the voluntary recall that they have initiated due to potential contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Geri-Tussin DM
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Ritussin DM Double Strength
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Iron Supplement Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Diocto Liquid Docusate Sodium Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Ritussin DM Children & Adults
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Diphenhydramine Oral Liquid Alcohol Free
cGMP Deviations: Products may have microbial contamination.
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).