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 in 2019
Every FDA drug recall initiated in 2019, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,788 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
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 III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Missing label; Product complaints reported missing bottle label.
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
Class I · High risk
Drospirenone and Ethinyl Estradiol Tablets
Failed dissolution specifications : failed results at the 3-month stability time point.
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.
Class II · Moderate risk
Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Grandall Oftal-Mycin Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Grandall Colirio Oftal-Mycin Redness Relief Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
FreshKote Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT retaine NaCl Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
OCuSOFT retaine NaCl Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack
Lack of Assurance of Sterility
Class II · Moderate risk
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Altaire Ciprofloxacin HCl Ophthalmic Solution
Lack of Assurance of Sterility