Class II · Moderate risk
Fresenius bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
FDA Drug Recalls
1,969 recalls, newest first
Class II · Moderate risk
Baxter LL bag 1% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Baxter Ultrabag 1.5% Amino Acids
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 34 - 39 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class III · Low risk
Budesonide Capsules
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Class II · Moderate risk
HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30…
Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)
Class I · High risk
Warfarin Sodium Tablets
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Class III · Low risk
Nicardipine Hydrochloride Injection 25 mg/10 mL
Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Class I · High risk
Trace Mineral-5 MDV
Non-Sterility; contract laboratory identified Staphylococcus warneri in the product
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class II · Moderate risk
Dicopanol FusePaq Kit for Oral Suspension
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Class III · Low risk
Derma-Smoothe/FS
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class I · High risk
Lightning ROD capsules
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Class I · High risk
Lightning ROD capsules
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.
Class II · Moderate risk
Pure-Aid Allergy Relief
Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine
Class II · Moderate risk
Gentamicin Sulfate Injection USP 80 mg/2 mL
Presence of Particulate Matter: visible particles were identified floating in the primary container.
Class II · Moderate risk
Tri-Mix Injections in 5 mL and 10 mL vials
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
MIC (Methionine, Inositol, and Choline)
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Praziquantel 56.8 mg
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Carnosine 5% Opth drop
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Morphine Sulfate 25 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Testosterone Cypionate 200 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
MIC (Methionine, Inositol, and Choline)
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Phosphatidyl Choline 10%
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
B-Complex 100 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes