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Class II Recall of Ten Lots of the Revaclear Capillary Dialyzer 300, Product Code 114745L

The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions.  Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401. Learn More

By |2020-09-23T12:08:23+00:00March 16th, 2020|alerts|0 Comments

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death. Recalled Product Volumat MC Agilia Infusion System and Vigilant Drug LibraryModelsVolumat MC Agilia Z021135, Software Versions 1.7 and 1.9aVigilant Drug Library Z073476, Software Versions 1.0 and 1.1Lot Numbers: AllManufacturing

By |2020-09-23T13:15:48+00:00August 15th, 2019|alerts|0 Comments

Par Pharmaceutical, Inc. Issues Voluntary Nationwide Recall of One Lot of Mycophenolate Mofetil for Injection

Endo International plc, announced today that one of its operating companies, Par Pharmaceutical, Inc., is voluntarily recalling one lot of Mycophenolate Mofetil for Injection, USP to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution. The administration of a glass particulate, if present in an intravenous

By |2020-09-23T13:15:39+00:00May 8th, 2019|alerts|0 Comments

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s

By |2019-11-05T18:27:00+00:00December 3rd, 2018|alerts|0 Comments