Class II · Moderate risk
traMADol Hydrochloride Tablets
Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Class II · Moderate risk
Progesterone 200 mg
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
Class II · Moderate risk
Haloperidol decanoate Injection 50mg/mL
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
Class II · Moderate risk
Cefdinir for Oral Suspension USP 125 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 250 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
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.