Class II · Moderate risk Terminated
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste…
Reason Lack of sterility assurance
Is Heparin recalled?
118 FDA recalls mention Heparin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Heparin.
Class II · Moderate risk Terminated
HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class I · High risk Terminated
Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10…
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained…
Class I · High risk Terminated
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5…
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained…
Class I · High risk Terminated
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (10…
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained…
Class I · High risk Terminated
Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Container, Rx Only Injection for Intravenous Use (5…
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained…
Class II · Moderate risk Terminated
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd…
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk Terminated
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd…
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk Terminated
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only…
Reason Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of…
Class II · Moderate risk Terminated
Heparin Pork 30,000 Units in NS 1000 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 mL per 75 mL, 60 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 20,000U/Marcaine 0.25%, 10 mL, Sodium Bicarbonate 8.4% 48 mL, 60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10 mL, Anderson Compounding Pharmacy 310 Bluff City…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10,000 U/Bupivacaine 0.5% 10 mL, Sodium Bicarbonate 8.4% 50 mL, 61 mL Syringe, Anderson Compounding Pharmacy 310 Bluff…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Saline 5 mL, 60 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Water 5 mL, 27 mL Syringe, Anderson Compounding…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff…
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units in 0.9% Sodium Chloride, QS 5 mL Sterile single use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HEPERAIN 50 mg/50 mL (1mg/mL) Injectable Solution, Heparin Sodium 0.45% Sodium Chloride QS Heparin 50 Units 50 mL, Sterile single…
Reason Labeling; Label Error on Declared Strength; label incorrectly states the concentration as 50 mg/50 mL (1 mg/mL) rather than the fully accurate…
Class II · Moderate risk Terminated
HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
HEPARIN 25,000 Units in 5% Dextrose (Heparin Sodium, USP 25,000 Units, 5% Dextrose Inj., USP 250 mL) Volume: 255 mL. Single dose…
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Heparin sodium all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
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