Class II · Moderate risk
Testosterone 200 mg/Anastrozole 9 mg Pellet
Superpotent and Subpotent drugs
FDA Drug Recalls
1,103 recalls, newest first
Class II · Moderate risk
Marcaine 0.5%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class II · Moderate risk
Marcaine 0.25%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Class III · Low risk
PREMARIN (conjugated estrogen tablets, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Class III · Low risk
Xanax (Alprazolam)
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class II · Moderate risk
Desoximetasone Cream USP
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Class III · Low risk
buPROPion Hydrochloride Extended-release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules
Superpotent Drug and Subpotent Drug; potency failures obtained
Class II · Moderate risk
Tri-Mix 18/1/10
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class III · Low risk
Cytotec (misoprostol)
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Class II · Moderate risk
Ondansetron HCI API
Microbial Contamination of Non-Sterile Product
Class III · Low risk
Lansoprazole Delayed-Release Capsules
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Class I · High risk
GlucaGen HypoKit
Defective delivery system: detached needles on the syringe in the kit.
Class III · Low risk
Varithena (polidocanol injectable foam)
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of sterility
Class I · High risk
Eye Wash
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
Class I · High risk
Hyoscyamine Sulfate
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.