Class II · Moderate risk
Trelstar (triptorelin pamoate)
Labeling: Label Error On Declared Strength: Trelstar 11.25 mg labeled carton/kit contained a vial labeled as 3.75 mg instead of a vial being labeled as 11.25mg.
FDA Drug Recalls
1,803 recalls · Class II, newest first
Class II · Moderate risk
0.45% Sodium Chloride Injection USP
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Class II · Moderate risk
Pantaprazole Sodium Delayed Release Tablets
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Class II · Moderate risk
Niacin Extended Release Tablets
Failed Tablet/Capsule Specifications: There is a potential for broken tablets.
Class II · Moderate risk
Mercuroclear Antiseptic Anesthetic First Aid Helps prevent…
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Class II · Moderate risk
Carisoprodol IV
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Class II · Moderate risk
Dollar General Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
Dr. Sheffield Triple Antibiotic Ointment
Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing
Class II · Moderate risk
Phenylephrine Nasal 1% Spray
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Class II · Moderate risk
10%, Travasol
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Class II · Moderate risk
Valacyclovir Hydrochloride Tablets
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Class II · Moderate risk
Sumatriptan Succinate Injection
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Class II · Moderate risk
Imitrex STATdose System
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Class II · Moderate risk
Carbon Dioxide
Labeling: Not Elsewhere Classified; Due to an error in the manufacturing procedure, a cylinder in liquid withdrawal service was not marked Syphon Tube indicating liquid withdrawal and shipped as a gas withdrawal cylinder.
Class II · Moderate risk
Clonazepam Tablets
Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.
Class II · Moderate risk
sertraline HCl tablets
Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
Class II · Moderate risk
Nifedipine
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
Class II · Moderate risk
PEGASPARGASE ONCASPAR Injection
Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
Class II · Moderate risk
Voriconazole 0.5mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Voriconazole 0.5mg/ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Voriconazole 1% opthal
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Vitamin D (Ergocalciferol)
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Vit A (olive oil)
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.