Category
Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIMorphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x 2 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-02
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIMorphine Sulfate Injection, USP, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-30
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIMorphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-979-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IILidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-985-05
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IILidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-949-05
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IILabetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIKetamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-511-01
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIKetamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-33
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIKetamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-982-55
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIHYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIHYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIHYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIHYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-529-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIGlycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-30
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIGlycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-903-05
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIFentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL*) bags, packaged as 10 x 1 IV bag per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-523-21
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIEPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-925-10
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIEPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia SC 29172, NDC: 69374-544-10
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIBupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine HCl 60 mg (1.2 mg/mL) Injection, 50 mL syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-514-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass II0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-947-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass II0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Ext., West Columbia, SC 29172, NDC: 69374-970-50
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIAtropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-935-03
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugNephron Sterile Compounding Center LLCClass IIAmino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing facility, 4500 12th Extension, West Columbia, SC 29172, NDC: 69374-988-10
Lack of Assurance of Sterility
- 2022-07-27FDA-DrugVi-Jon, LLCClass IIHydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woo
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
- 2022-07-20FDA-DrugLatin Foods MarketClass IArti King Refozado con Ortiga y Omega 3 Tablets, 100-count bottles, Hecho en Mexico por: "PLANTAS MEDICINALES DE MEXICO", Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800 Mexico, UPC 7 501031 111138
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGlutathione 200mg/ml, a) 10ml-vial, b) 30ml-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIVitamin D3 50,000IU/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIVitamin B-Complex Preservative Free, 3ml-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIVitamin B-Complex, a) 10 mL-vial, b) 30 mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IITestosterone Propionate 100mg/ml, 10mL-vial, Room temperature, Tailor Made Compounding
Lack of Assurance of Sterility
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