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.
FDA Drug Recalls
1,586 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
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.
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
Class II · Moderate risk
CVS Health Multi-Action Relief Drops
Lack of Assurance of Sterility
Class II · Moderate risk
CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free
Lack of Assurance of Sterility
Class II · Moderate risk
Puralube Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Puralube Petrolatum Ophthalmic Ointment
Lack of Assurance of Sterility
Class II · Moderate risk
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack
Lack of Assurance of Sterility