Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIPHENYLephrine 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
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA SOLUTION, 25 mEq K, SUTTER CARDIOPLEGIA, Total Volume = 572.64 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0217-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal 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 Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal 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, AZ 85043, NDC: 72196-0431-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal TPN Starter Bag, Amino Acids (trophamine) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal 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 Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal 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, NDC: 72196-0406-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IINeonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IIrocuronium 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.
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICardioplegia 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 Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA 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: 72196-0105-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA 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: 72196-0100-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-09-06FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICARDIOPLEGIA 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: 72196-0103-1
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
- 2023-08-30FDA-DrugTMC Acquisitions LLC dba Tailor Made CompoundingClass IINAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.
Lack of Assurance of Sterility
- 2023-08-30FDA-DrugTMC Acquisitions LLC dba Tailor Made CompoundingClass IISemaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Lack of Assurance of Sterility
- 2023-08-30FDA-DrugInmar Supply Chain Solutions, LLCClass IIAll Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.
- 2023-08-30FDA-DrugBaxter Healthcare CorporationClass IIIBendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- 2023-08-30FDA-DrugEcometics, Inc.Class IILugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and potassium iodide 0.100gm, 8mL Single Use Vials, Rx Only, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6064-0, Ref 6064.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIAstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIactivator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% in diluted Activator Solution, Net 1 FL. OZ., Manufactured for: All USA Direct, LLC, Broadview, IL 60155.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIUnguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide 6.6%), labeled as a) NET WT 1 OZ (28 g) tubes, Improved Formula, UPC 0 11169 10216 0, and b) NET WT 1 OZ (28.3g) tubes, Maximum Strength, UPC 0 11169 11250 3, Distributed by: Oakhurst Company, Levittown, NY 11756.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged in a 7 FLUID OZ (207 ml) bottles, UPC 7 18864 20102 9 and b) 16 FLUID OZ (472 ml) bottles, UPC 7 18864, 20110 4, Distributed by: The Larkspur Group, Inc., Norwalk, CT 06854.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIYAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, packaged in a) 4 FL OZ (118 mL) bottles, UPC 0 11169 00004 6, and 8 FL OZ (236 mL) bottles, UPC 0 11169 00008 4, The Oakhurst Co., Dist., Levittown, NY 11756.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugEcometics, Inc.Class IIBlis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bottles, UPC 0 11169 20011 8 and b) 1.85 FLUID OZ. (54.5 mL) bottles, UPC 0 11169 20012 5, Distributed by Oakhurst Company, Levittown, NY 11756.
CGMP Deviations: Products not manufactured under current good manufacturing practices.
- 2023-08-30FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIITrandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale -Bardez, Goa 403513, India, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-295-01
Subpotent: Out of Specification for Assay Test at the 3-month time point.
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