Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
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
Class II · Moderate risk
TheraTears Extra
Lack of Assurance of Sterility
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral…
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC…
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Fulvestrant Injection 250 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug
Class II · Moderate risk
Rompe Pecho Max Multi-Symptoms Maximum Strength
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho Ex Expectorant
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho DM
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Rompe Pecho CF Cold & Flu Advanced Formula
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Lyrica CR (pregabalin)
Failed Dissolution Specifications