Class II · Moderate risk
Asma Aid Distributed by Herbal Doctor Remedies Alhambra
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa
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
Wonder Freeze Pain Releiving Gel with ILEX
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
Kool Comfort Cooling Pain Relief
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
Cool Hot Ice Analgesic 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
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.
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
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Milrinone Lactate Injection 200 mcg
Lack of Assurance of Sterility: Bags have the potential to leak.
Class II · Moderate risk
Gablofen (baclofen injection)
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.