Class II · Moderate risk
Dexpanthenol 250mg/mL
Lack of Assurance of Sterility
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Calcium Chloride Preservative Free
Lack of Assurance of Sterility
Class II · Moderate risk
Biotin 5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
BCAAs (Leucine/Iso-Leucine/Valine)
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid 500mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Anastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alpha Lipoic Acid 25mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Alprazolam C-IV 2 mg
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
Alprazolam C-IV 1 mg 60-count bottles
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Class II · Moderate risk
HEB 50% Isopropyl Alcohol First Aid Antiseptic
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% 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. The back label is correct. Product is packaged in dark bottles.
Class II · Moderate risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of sterility assurance: leaking bags
Class II · Moderate risk
hydrALAZINE HCl Tablets
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk
Alprazolam Tablets
CGMP deviations
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
All Over-The-Counter
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
cGMP deviations
Class II · Moderate risk
Pyrazinamide Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations