Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
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.
14,535 recalls, newest first.
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Cloderm (clocortolone pivalate)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Amphotericin B Liposome for Injection
Out of specification for assay
Class II · Moderate risk
Ful-Glo
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk
Ful-Glo
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk
GloStrips
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk
GloStrips
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Gordofilm Wart Remover
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit