DrugFeb 3, 2016
Sentara Enterprises GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML recall — FDA D-0641-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
Monthly breakdown
2016 recalls by month
Select a month to review the recall records reported during that period.
December 2016251 records · 2 categoriesNovember 2016140 records · 2 categoriesOctober 2016469 records · 2 categoriesSeptember 2016304 records · 3 categoriesAugust 2016156 records · 3 categoriesJuly 2016295 records · 2 categoriesJune 2016155 records · 2 categoriesMay 2016210 records · 2 categoriesApril 2016193 records · 2 categoriesMarch 2016166 records · 2 categoriesFebruary 2016176 records · 2 categoriesJanuary 201693 records · 2 categories
2016 recalls — page 105
Records are ordered by the best available source date.
DrugFeb 3, 2016
Sentara Enterprises DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) recall — FDA D-0622-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Tropicamide Ophthalmic Solution USP, 1% recall — FDA D-0647-2016
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class IIIFDA: TerminatedBausch & Lomb, Inc.
DrugFeb 3, 2016
Sentara Enterprises VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in recall — FDA D-0623-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML recall — FDA D-0630-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Amerisource Health Services Levofloxacin Tablets USP, 500 mg recall — FDA D-0610-2016
Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.
Class IIFDA: TerminatedAmerisource Health Services
DrugFeb 3, 2016
Perrigo Company PLC Guaifenesin Grape liquid 100 mg/5 mL recall — FDA D-0586-2016
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class IIFDA: TerminatedPerrigo Company PLC
DrugFeb 3, 2016
Tropicamide Ophthalmic Solution USP, 0.5% recall — FDA D-0646-2016
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class IIIFDA: TerminatedBausch & Lomb, Inc.
DrugFeb 3, 2016
Sentara Enterprises GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG recall — FDA D-0626-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises SOD CHLORIDE (Sodium Chloride) recall — FDA D-0613-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in recall — FDA D-0628-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in recall — FDA D-0632-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in recall — FDA D-0616-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML recall — FDA D-0615-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% recall — FDA D-0645-2016
Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.
Class IIIFDA: TerminatedBausch & Lomb, Inc.
DrugFeb 3, 2016
Sentara Enterprises HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in recall — FDA D-0625-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Sentara Enterprises Lactated Ringers recall — FDA D-0636-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugFeb 3, 2016
Perrigo Company PLC Guaifenesin DM Cherry liquid recall — FDA D-0587-2016
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class IIFDA: TerminatedPerrigo Company PLC
DrugFeb 3, 2016
Sentara Enterprises Dextrose-NaCl (D5-1/2NS) in NS recall — FDA D-0620-2016
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class IIFDA: TerminatedSentara Enterprises
DrugJan 27, 2016
Phentermine Hydrochloride Capsules, USP, 15 mg recall — FDA D-0574-2016
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class IIIFDA: TerminatedPD-Rx Pharmaceuticals, Inc.
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray recall — FDA D-0577-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Grato Holdings Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz recall — FDA D-0580-2016
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class IIFDA: TerminatedGrato Holdings, Inc.
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" recall — FDA D-0582-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
DrugJan 27, 2016
Pine Pharmaceuticals Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for recall — FDA D-0584-2016
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Class IIFDA: TerminatedPine Pharmaceuticals, LLC
About the 2016 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.