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.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IHoly Cross Hospital (MD) AA3%TPN Neonatal Day 1 Bag, Trophamine 10%/3% Dextrose 70%/10%, Additives: Calcium Gluconate 0.46 mEq/mL, 5mEq, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IOlathe Medical Center (KS) NICU TPN Starter: Ingredients per 80 ml, Trophamine 3g Dextrose 10%, Additives: Calcium Gluconate 250mg, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IMethodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dextrose 5%, Additives: heparin PF 100 units/mL, 50 units/dL, Calcium Gluconate 0.46 mEq/mL, 200 mg/dL, compound vol: 300 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IAdvocate Good Samaritan Hospital (IL) TPN Dextrose 10% Trophamine 2%, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IAdvocate Good Samaritan Hospital (IL) TPN Dextrose 5% Trophamine 2%, Trophamine 5% Dextrose 2%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IAdventist Hinsdale Hospital (IL) Neonatal Starter: Troph 2% Dex10%, Trophamine 2% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IAdventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine 4% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IBridgeport Hospital (CT)TPN Neonatal Standard Solution, Trophamine 6% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, Calcium Gluconate 4mEq/L, compound vol: 150 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IThe Medical Center of Aurora (CO) Neonate Starter 2% AA/D10W, Trophamine 2% Dextrose 10%, compound vol: 250 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IRose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IRose Medical Center (CO) Neonate D10 Bridge, Trophamine 3% Dextrose 10%, Additives: heparin PF 0.5 unit(s)/ml, compound vol: 350 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IChildren's Hospital Colorado Springs TPN Neonate Starter Bag 4% AA/10% DEX, Trophamine 4% Dextrose 10%, compound vol: 500 ml, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box, each container is lined with a polystyrene insert; CAPS, Allentown, PA.
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IUniversity of Alabama Birmingham TPN Neonatal Starter Bag, compound vol: 100 ml, Trophamine 4% Dextrose 10%, sterile injectable, Rx only, compounded drug, IV infusion bag packaged in a corrugated box. each container is lined with a polystyrene insert; CAPS, Allentown, PA
Non-Sterility: Out of specification results for the sterility test for microbial contamination.
- 2015-04-15FDA-DrugRemedyRepack Inc.Class IIKETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
Crystallization
- 2015-04-15FDA-DrugHospira Inc.Class IIKETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Crystallization
- 2015-04-15FDA-DrugHospira Inc.Class IIKETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
Crystallization
- 2015-04-15FDA-DrugHeritage Pharmaceuticals, Inc.Class IIGLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
- 2015-04-15FDA-DrugMylan Pharmaceuticals Inc.Class IIIFexofenadine HCl Tablets, USP, 60 mg, Allergy, Antihistamine, Indoor and Outdoor Allergies, Non-Drowsy, Original Prescription Strength, a) 60 count Bottles, NDC 0378-0781-91, b) 500 count Bottles, NDC 0378-0781-05, Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, USA.
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
- 2015-04-15FDA-DrugWallcur IncorporatedClass IPracti-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or animals.
- 2015-04-15FDA-DrugHospira Inc.Class IMitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
- 2015-04-15FDA-DrugNavinta LLCClass IIFomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impacting product quality and sterility.
- 2015-04-08FDA-DrugAmerican Health PackagingClass IIBenzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 --- NDC 68084-214-01(carton) NDC 68084-214-11 (individual dose)
Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsules
- 2015-04-08FDA-DrugBaxter Healthcare CorpClass II0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Lack of Assurance of Sterility; increased complaints received for leaks
- 2015-04-08FDA-DrugBaxter Healthcare CorpClass IIClinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Lack of Assurance of Sterility; increased complaints received for leaks
- 2015-04-01FDA-DrugAmerican Specialty PharmacyClass IIHydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
- 2015-04-01FDA-DrugBaxter Healthcare Corp.Class II5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
- 2015-04-01FDA-DrugBaxter Healthcare Corp.Class II0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
- 2015-04-01FDA-DrugBethel Nutritional Consulting, IncClass IIB-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss
- 2015-04-01FDA-DrugMatheson, Inc.Class IIIAIR COMPRESSED, Medical Air, USP, Rx Only. Matheson Tri-Gas, Inc., 150 Allen Road, Basking Ridge, NJ 07920. Available in A) E or 22 cu ft cylinder, NDC: 55037-302-09; B) 40 cu ft cylinder, NDC: 55037-302-10; C) 200 cu ft cylinder, NDC: 55037-302-15; D) 220 cu ft cylinder, NDC: 55037-302-16; E) 300 cu ft cylinder, NDC: 55037-302-18, 55037-302-19, 55037-302-20.
Failed Impurities/Degradation Specification; out of specification results for carbon dioxide
- 2015-04-01FDA-DrugMylan Institutional LLCClass IIHaloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Lack of Assurance of Sterility; due to leaking vials
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