Class II · Moderate risk
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ.
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
390 recalls · Class II, newest first
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
Soothe&Cool Protect Moisture Guard Skin Protectant
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
Hydrocortisone Cream
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
Hydrocortisone Cream
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
Hydrocortisone Cream With Aloe
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
Hydrocortisone Cream With Aloe
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
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.