Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
FDA Drug Recalls
18,003 recalls, newest first
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.
Class III · Low risk
Vyvanse (lisdexamfetamine dimesylate)
Presence of Foreign Tablets/Capsules
Class III · Low risk
Mozobil (plerixafor injection)
Labeling: Incorrect or Missing Package Insert
Class III · Low risk
Ramipril Capsules
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class III · Low risk
ZENATANE (isotretinoin capsules USP)
Failed Dissolution Specifications
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Class II · Moderate risk
Dextroamphetamine Saccharate
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule