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Showing 2641–2660 of 3363 results

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Tecan US, Inc.: Infinite 200PRO The Tecan Infinite 200 is a multifunctio...

Incorrect lumi firmware version installed (E.027 instead of V2.00)

Class IIILow

FDANov 10, 2014MD• Tecan US, Inc.

Vancomycin Injection (Hospira) – product mislabeling (2014)

Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.

Class IIILow

FDANov 7, 2014Nationwide• Hospira Inc.

Illumina Inc: Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assa...

Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.

Class IIILow

FDANov 6, 2014MD, NY• Illumina Inc

Coca Cola Zero (Coca-Cola) – ingredient inconsistency (2014)

Equipment malfunction led to ingredients to be blended at levels that are inconsistent with approved formulations.

Class IIILow

FDANov 5, 2014IN, KY, OH• Coca-Cola Company (The)

Novadaq Technologies, Inc.: Non-sterile drape

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

Class IIILow

FDANov 4, 2014Nationwide• Novadaq Technologies, Inc.

Pickled Labneh with Pepper (Baroody Imports) – undeclared preservatives (2014)

Undeclared Allergen

Product contains undeclared sorbic acid and undeclared sulfites (preservative)

Class IIILow

FDANov 4, 2014NY• Baroody Imports Inc.

Novadaq Technologies, Inc.: LUNA Chest, Model No. LU4006

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

Class IIILow

FDANov 4, 2014Nationwide• Novadaq Technologies, Inc.

Pickled Labneh with Garlic (Baroody Imports) – undeclared additive (2014)

Undeclared Allergen

Product contains undeclared sorbic acid

Class IIILow

FDANov 4, 2014NY• Baroody Imports Inc.

CooperSurgical, Inc.: Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562...

The product has been identified to contain an incorrect curette type.

Class IIILow

FDAOct 27, 2014MO, NV, NY• CooperSurgical, Inc.

Chocolate Chip Mini Muffins (LaBree's) – foreign material (2014)

Product contains foreign material

Class IIILow

FDAOct 27, 2014MI, NY• LaBree's Bakery

Chlorhexidine Surgical Scrub (CareFusion) – concentration issue (2014)

Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.

Class IIILow

FDAOct 24, 2014Nationwide• CareFusion 213, LLC

AGFA Healthcare Corp.: Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Rad...

Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

Class IIILow

FDAOct 24, 2014Nationwide• AGFA Healthcare Corp.

Medtest Holdings, Inc.: MedTest DX Assayed Human Multi Sera Control Level 1 (HNC2...

MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) control values are outside of specification.

Class IIILow

FDAOct 23, 2014Nationwide• Medtest Holdings, Inc.

Carbamazepine Tablets (Taro Pharmaceuticals) – unauthorized sale (2014)

Marketed without an Approved NDA/ANDA: One lot was on hold-pending release status when it was erroneously made available for sale in the inventory control system. An alternate manufacturing site for the Carbamazepine API final intermediate was pending approval.

Class IIILow

FDAOct 21, 2014IL, LA, OH• Taro Pharmaceuticals U.S.A., Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 10...

A typographical error regarding the expiration date was identified in the control module instructions for use.

Class IIILow

FDAOct 20, 2014CA, FL, KY +6 more• Siemens Healthcare Diagnostics, Inc.

Z-COTE Zinc Oxide (Nanophase Technologies) – manufacturing error (2014)

cGMP Deviation; The incorrect amount of a raw material was added during the manufacture of two lots of Z-COTE HP 1.

Class IIILow

FDAOct 20, 2014NJ• Nanophase Technologies Corporation

Biomerieux: Etest¿ Ceftaroline (CPT32) WWB100. Etest¿ (Antimicrobi...

The products have a wrong expiration date on their labeling, 5 years instead of 2 years.

Class IIILow

FDAOct 16, 2014Nationwide• Biomerieux

Candesartan Cilexetil Tablets (Apotex) – Impurity Specifications (2014)

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Class IIILow

FDAOct 16, 2014Nationwide• Apotex Inc.

Candesartan Cilexetil Tablets (Apotex) – Impurity Specifications (2014)

Failed Impurities/Degradation Specifications: Out of specification (OOS) results were observed for CAD-II, CAD-V and Total Impurities.

Class IIILow

FDAOct 16, 2014Nationwide• Apotex Inc.

Biomerieux: Etest¿ Ceftaroline (CPT32) US B30. Etest¿ (Antimicrobi...

The products have a wrong expiration date on their labeling, 5 years instead of 2 years.

Class IIILow

FDAOct 16, 2014Nationwide• Biomerieux

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