Class II · Moderate risk
Proplete 70+ KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions
FDA drug recalls in 2013
Every FDA drug recall initiated in 2013, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
2,085 recalls, newest first.
Class II · Moderate risk
Proplete 60 - 69 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 52 - 59 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Proplete 40 - 44 KG
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Class II · Moderate risk
Idpn
Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
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
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