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Prescription medicine recalls

Prescription drugs recalled for contamination, potency or labelling.

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2,003 recalls · newest first

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, N

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 200 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 4100 syringes affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 786 Bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 577 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 84 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenu

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 140 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Aven

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 108 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 703 bags. affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 292 bags. affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 184 affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 3519 Syringes affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 92 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 17, 2023Serious

Central Admixture Pharmacy Services, Inc. — CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC

Prescription medicine · Central Admixture Pharmacy Services, Inc. · 304 bags affected

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Food & drug recall · FDAAugust 16, 2023Labelling issue

Esperion — Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only

Prescription medicine · Esperion · 45,240 bottles affected

Failed dissolution specifications: below specification results at stability 12-month

Food & drug recall · FDAAugust 15, 2023Serious

TMC Acquisitions LLC dba Tailor Made Compounding — Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

Prescription medicine · TMC Acquisitions LLC dba Tailor Made… · 9 vials affected

Lack of Assurance of Sterility

Food & drug recall · FDAAugust 15, 2023Serious

TMC Acquisitions LLC dba Tailor Made Compounding — NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

Prescription medicine · TMC Acquisitions LLC dba Tailor Made… · 99 vials affected

Lack of Assurance of Sterility

Food & drug recall · FDAAugust 14, 2023Labelling issue

Glenmark Pharmaceuticals Inc., USA — Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only

Prescription medicine · Glenmark Pharmaceuticals Inc., USA · 1,200 bottles affected

Subpotent: Out of Specification for Assay Test at the 3-month time point.

Food & drug recall · FDAAugust 14, 2023Labelling issue

Baxter Healthcare Corporation — Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only

Prescription medicine · Baxter Healthcare Corporation · 13,502 vials affected

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

Food & drug recall · FDAAugust 14, 2023Labelling issue

Caplin Steriles Limited — Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only

Prescription medicine · Caplin Steriles Limited · 19, 820 vials affected

Failed Impurities/Degradation Specifications

Food & drug recall · FDAAugust 11, 2023Serious

Baxter Healthcare Corporation — DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Pr

Prescription medicine · Baxter Healthcare Corporation · a) 44,520; b) 60,762; c) 483,912 affected

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.