Class II · Moderate risk
Calcium Edta 300 Mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
Calcium Edta 200 Mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Buprenorphine 0.1/0.05 Mg/Ml Cream
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
B-12 Rejuv 25 Mg/Ml Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Alprostadil 100 Mcg/Ml Inj Soln
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Zinc Sulfate 1 mg/ml INJECTABLE
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Vitamin D 50
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Vitamin B-Complex Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Triptropin Plus Injectable
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Triamcinolone Acetonide 80 Mg/Ml Inj Susp
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Testosterone Propionate 100 Mg/Ml Oil Inj Soln
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Testosterone Cypionate 100 Mg/Ml
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE…
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Sodium Phosphate Monobasic/Water for Injection 10%
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Sodium Phosphate Dibasic/Water for Injection 10%
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Latanoprost Ophthalmic Solution
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Class II · Moderate risk
ChloraPrep With Tint
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Class I · High risk
Calcium Chloride Preservative Free Sterile injection
Non-Sterility: The firm's contract testing laboratory found sterility failures.
Class II · Moderate risk
Cefazolin
Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through review of retained samples.
Class II · Moderate risk
Yohimbine 10 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Xylazine 300 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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