Class II · Moderate risk Terminated
Lotrimin Af
Reason cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Terminated
Coppertone Pure & Simple 50 Sunscreen Spray
Reason cGMP Deviations
Class II · Moderate risk Terminated
Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Artesunate for Injection
Reason Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class II · Moderate risk Terminated
Hydroquinone USP
Reason Finished product specification did not meet USP specifications.
Class II · Moderate risk Terminated
Testosterone Cypionate Testosterone Propionate
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 55/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 232/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
AirDuo Digihaler 113/14
Reason Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk Terminated
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sodium Phenylbutyrate Powder
Reason Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk Terminated
Cleaning Solutions Foaming Hand Sanitizer
Reason CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk Terminated
ceFAZolin 3 G in 0.9% Sodium Chloride
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
ceFAZolin
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate Injection
Reason Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk Terminated
GlipiZIDE Extended-Release Tablets
Reason Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk Terminated
Valproic Acid Oral Solution
Reason CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk Terminated
Zonisamide 100 mg Capsules
Reason CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk Terminated
Rocuronium Bromide Injection 50mg/5 mL
Reason Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
Class II · Moderate risk Terminated
Metoprolol Tartrate Tablets USP 100 mg
Reason Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class II · Moderate risk Terminated
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ
Reason Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces