Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
FDA Drug Recalls
1,969 recalls, newest first
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
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 III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
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 I · High risk
Adipotrim XT
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
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 III · Low risk
Bumetanide Tablets USP 0.5 mg. Rx Only
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
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 III · Low risk
Glipizide XL
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Class III · Low risk
Glucotrol XL
Failed Dissolution Specification; 8 hr stability timepoint
Class I · High risk
Hydravax High Potency Diuretic Weight Loss Solution
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Class I · High risk
Soliris (eculizumab)
Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.
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.