Class II · Moderate risk Terminated
Cardia Forte
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Bone Fixer
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Baby Saver Capsules
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Awake
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Asthma Balm 60 gram
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Asma Aid Distributed by Herbal Doctor Remedies Alhambra
Reason CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class II · Moderate risk Terminated
Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone…
Reason CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class II · Moderate risk Terminated
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa
Reason 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 Terminated
Wonder Freeze Pain Releiving Gel with ILEX
Reason 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 Terminated
Kool Comfort Cooling Pain Relief
Reason 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 Terminated
Cool Hot Ice Analgesic Gel
Reason 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 Terminated
CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ.
Reason 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 Terminated
CVS Health Glycerin Suppositories
Reason 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 Terminated
Soothe&Cool Protect Moisture Guard Skin Protectant
Reason 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 Terminated
Hydrocortisone Cream
Reason 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 Terminated
Hydrocortisone Cream
Reason 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 Terminated
Hydrocortisone Cream With Aloe
Reason 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 Terminated
Hydrocortisone Cream With Aloe
Reason 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 Terminated
Adult Glycerin Suppositories
Reason 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 Terminated
Adult Glycerin Suppositories
Reason 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 Terminated
Adult Glycerin Suppositories
Reason 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 Terminated
Children Glycerin Suppositories Laxative for ages 2 to 5. Package…
Reason 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 Terminated
CVS Therapeutic Menthol Gel
Reason 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 Terminated
Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion
Reason 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 Terminated
CVS Health Glycerin Suppositories
Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.