Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-07-15FDA-DrugBaxter Healthcare Corp.Class ILactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
- 2015-07-15FDA-DrugBaxter Healthcare Corp.Class I10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
- 2015-07-15FDA-DrugBaxter Healthcare Corp.Class I5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
- 2015-07-15FDA-DrugBaxter Healthcare Corp.Class I0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
- 2015-07-15FDA-DrugBethel Nutritional Consulting, IncClass ISLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
- 2015-07-15FDA-DrugTeva Pharmaceuticals USAClass IAdrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
- 2015-07-08FDA-DrugQualitest PharmaceuticalsClass IIIDisulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
- 2015-07-08FDA-DrugTakeda Pharmaceuticals North America, Inc.Class IICONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
- 2015-07-08FDA-DrugLincare, Inc.Class IIGentamicin Sulfate, GENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Qty: 7 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIGanciclovir Sodium, 250MG / NS 100ML, QTY: 6 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIFluorouracil 4250mg / D5W 285mL, Qty: 1 285 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIHYDROmorphone HCl PF, Hydromorphone 1000 mg / NS 500 mL, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IICeftazidime 2 gm / NS 50mL, Qty: 15 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIMorphine Sulfate, MORPHINE SULFATE 1000mg / NS 100mL, Qty: 1 50 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IICefepime HCl, CEFEPIME 850 mg NS 50mL AccuFlo, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIPotassium Chloride, Dextrose 5% LR 1000 mL with 40mEq KCL, Qty: 1 1000 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin 1000mg / NS 100mL, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin 750 mg/NS 100 ml accuflo, Packaged in 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIGENTAMICIN 14.4 mg / NS 30 mL SYRINGE, Packaged in 30 mL Syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIPfizerpen-G 4.2 MU / SW 240 mL AccuFlo, Packaged in 2 240 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assure
- 2015-07-08FDA-DrugLincare, Inc.Class IICefepime HCl, Cefepime 2 gm / NS 100 mL AccuFlo, Qty: 14 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin HCl/Heparin, Vancomycin 50mcg/mL / Heparin 100u/mL, Qty: 3, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin HCl, Vancomycin 1500mg / D5W 265mL, Qty: 2 265 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIDiphenhydramine HCl, Diphenhydramine 25mg / NS 10 ml syringe, Qty: 2 10 mL syringes, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IICeftriaxone Sodium, Ceftriaxone 2gm / NS 50mL, Qty: 12 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin, VANCOMYCIN 750mg / NS 100mL AccuFlo, Qty: 7 100 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIFentanyl Citrate, FENTANYL 25,000 MCG / 500 ML, Qty: 1 500 mL Bag, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IIVancomycin HCl / Heparin, Vancomycin 50mcg/ml / HEPARIN 100u/ml, Qty: 8, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IICIPROFLOXACIN 400MG / D5W 200ML ACCUFLO, Packaged in 3 200 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
- 2015-07-08FDA-DrugLincare, Inc.Class IICEFEPIME 1gm / NS 50mL AccuFlo, Packaged in 50 mL Bags, Rx Only. Compounded by: United Medical IV Center (Little Rock) 1527 South Bowman Rd. Ste. D Little Rock, AR 72211-4200.
Lack of Assurance of Sterility: Sterility of product is not assured.
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