Brookfield Prescription Center Inc. dba MD Custom Rx Recalls

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

FDAMay 30, 2014WI• Brookfield Prescription Center Inc. dba MD Custom Rx

HCG 200 Units Drops (MD Custom Rx) – incorrect solvent (2014)

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

FDAMay 30, 2014WI• Brookfield Prescription Center Inc. dba MD Custom Rx

Chevre (Caromont Farm) – Pasteurization Failure (2014)

Failure to achieve proper pasteurization due to one or more of the following critical factors: Improper Air space temperature, Pasteurization time, and/or Milk Temperature.

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Class IIModerate

FDAMay 30, 2014Nationwide• Caromont Farm

Diphenhydramine (Brookfield) – Incorrect Solvent (2014)

Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.

FDAMay 30, 2014WI• Brookfield Prescription Center Inc. dba MD Custom Rx

Coca Cola Vanilla (Coca-Cola) – undeclared aspartame (2014)

The product contains undeclared aspartame.

FDAMay 29, 2014CO, KS, NM +3 more• The Coca-Cola Company

Fluvastatin Capsules (Teva) – failed specifications (2014)

Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

FDAMay 29, 2014Nationwide• Teva Pharmaceuticals USA

Trident UV Pool Sanitation Systems – fire hazard (2014)

Fire/Burn Risk

This recall involves all Trident Series 2 ultraviolet sanitation systems for pools. The sanitation systems are a gray tube that stands 32 inches high by 11 inches in diameter. They are plumbed into the pool's water circulation pipes and plugged in or hard-wired into an electrical system. The pool's water runs through the unit and is sanitized by ultraviolet lamps. This is a secondary sanitation system used in conjunction with chemical sanitizers such as chlorine or bromine. "Trident Ultraviolet Corporation," "Series 2" and "UV Ultraviolet Sanitation System" are printed on a black label on the front of the units. "Trident Series 2 Ultraviolet Water Treatment System" and a series of letters for the date code are printed on a silver sticker on the units. Go to www.uvrecall.org to determine if the date code is included in the recall.

CPSCMay 29, 2014Nationwide• Trident Ultraviolet Corp., of Marina del Rey, Calif. (this company is out of business but is handling this recall)

Del Nido Cardioplegia (Central Admixture) – microbial contamination (2014)

Non Sterility; microbial contamination identified as Aspergillus species

FDAMay 28, 2014MI, WI• Central Admixture Pharmacy Services, Inc.

Adenosine Injection (Central Admixture) – microbial contamination (2014)

Non Sterility; microbial contamination identified as Aspergillus species

FDAMay 28, 2014MI, WI• Central Admixture Pharmacy Services, Inc.

2014 CHAMPION BUS DEFENDER – champion bus, inc (2014)

Champion Bus, Inc. (Champion) is recalling certain model year 2014 Defender shuttle buses built on Freightliner M2 chassis equipped with IMMI-brand L9 seat belt buckles. When the button is pressed to release the seat belt, the latch plate can become partially engaged with the buckle, making the seat belt difficult to unlatch. Thus, these vehicles fail to conform to the requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 209, "Seat Belt Assemblies."

NHTSAMay 28, 2014Nationwide• CHAMPION BUS

Pediatric Cardioplegia (Central Admixture) – microbial contamination (2014)

Non Sterility; microbial contamination identified as Aspergillus species

FDAMay 28, 2014MI, WI• Central Admixture Pharmacy Services, Inc.

Foradil Aerolizer (Novartis) – failed stability test (2014)

Failed Stability Specification; out of specification result for particle size distribution during stability testing

FDAMay 28, 2014Nationwide• Novartis Pharmaceuticals Corp.

Low Potassium Cardioplegia (Central Admixture) – microbial contamination (2014)

Non Sterility; microbial contamination identified as Aspergillus species

FDAMay 28, 2014MI, WI• Central Admixture Pharmacy Services, Inc.

2014 CHAMPION BUS DEFENDER – champion bus, inc (2014)

Champion Bus, Inc. (Champion) is recalling certain model year 2014 Defender shuttle buses built on Freightliner M2 chassis, equipped with Eaton-brand hybrid automated transmissions. The software controlling the affected transmissions may improperly raise the vehicle's engine speed during downshifts without the driver's input.

NHTSAMay 28, 2014Nationwide• CHAMPION BUS

Shelled Walnuts (Farmers Market) – listeria risk (2014)

Listeria

Belleville Farmer's Market of Belleville, IL is recalling its packages of Shelled Walnuts because they have the potential to be contaminated with Listeria monocytogenes.

FDAMay 23, 2014IL• Farmers Market

Fluorescent Shop Lights (Cordelia Lighting) – Fire Hazard (2014)

Fire/Burn Risk

This recall involves Commercial Electric brand basic hanging shop lights that use two, 48-inch, two-pin, T8, fluorescent lamps. The recalled shop light is a metal light fixture with four plastic lamp sockets and a white finish. It is 48 inches long, 4.25 inches wide and 2.5 inches high and has two 10.5-inch long chains for hanging. The lamp sockets must be snapped into place during installation. Model number CESL401-06 and SKU number 201-462 are printed on a white label on the top of the fixture.

CPSCMay 22, 2014Nationwide• Cordelia Lighting Inc., Rancho Dominguez, Calif.

Ciprofloxacin Tablets (Aidarex) – foreign tablet mix-up (2014)

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

FDAMay 22, 2014Nationwide• Aidarex Pharmaceuticals LLC

Vaseretic Tablets (Valeant) – incorrect package insert (2014)

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset

FDAMay 21, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Vasotec Tablets (Valeant) – incorrect package insert (2014)

Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.

FDAMay 21, 2014Nationwide• Valeant Pharmaceuticals North America LLC

Isoniazid Tablets (West-Ward) – dissolution failure (2014)

Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.