Class II · Moderate risk
Coppertone Pure & Simple baby 50 Sunscreen Spray
cGMP Deviations
FDA Drug Recalls
921 recalls · Class II, newest first
Class II · Moderate risk
Coppertone Pure & Simple kids 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
Coppertone Pure & Simple 50 Sunscreen Spray
cGMP Deviations
Class II · Moderate risk
The Natural Dentist Healthy Balance Peppermint Sage
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class II · Moderate risk
Potassium Chloride Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Artesunate for Injection
Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Class II · Moderate risk
Hydroquinone USP
Finished product specification did not meet USP specifications.
Class II · Moderate risk
Testosterone Cypionate Testosterone Propionate
Lack of Assurance of Sterility
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 55/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 232/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
AirDuo Digihaler 113/14
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Class II · Moderate risk
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS
Lack of Assurance of Sterility
Class II · Moderate risk
Sodium Phenylbutyrate Powder
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Cleaning Solutions Foaming Hand Sanitizer
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
Class II · Moderate risk
ceFAZolin 3 G in 0.9% Sodium Chloride
Lack of sterility assurance.
Class II · Moderate risk
ceFAZolin
Lack of sterility assurance.
Class II · Moderate risk
Morphine Sulfate Injection
Defective container: Cracked vials leading to lack of sterility assurance
Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk
Valproic Acid Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Zonisamide 100 mg Capsules
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Class II · Moderate risk
Rocuronium Bromide Injection 50mg/5 mL
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
Metoprolol Tartrate Tablets USP 100 mg
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Class II · Moderate risk
Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ
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