FOR IMMEDIATE RELEASE - July 13, 2015 – In April 2015, Mylan Institutional conducted a voluntary market withdrawal of 14 lots of Calcium Chloride Intravenous Infusion 10%w/v, packaged in 10 mL prefilled syringes (listed below). In June 2015, Mylan Institutional issued a second notification of the market withdrawal.
Starcraft RV (Starcraft) is recalling certain model year 2014-2016 AR-ONE TT trailers and 2014-2016 Comet CT Hard Sided camping trailers, models 28V, 28P, 28R, 28S, 28V, 28W, BC, and BH, manufactured June 3, 2013, to February 6, 2015 and equipped with the Extreme Package Option. The affected trailers have Certification labels that incorrectly state a tire size of ST205/75R 14C when the actual tire size is LT235/75R 15C. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."
Spartan Motors, Inc. (Spartan) is recalling certain model year 2010-2015 Furion, Gladiator, and Metrostar emergency response vehicles manufactured November 10, 2009, to June 16, 2015. In the affected vehicles, the engine cooling fan may crack and the fan blades may detach while the fan is spinning.
Ford Motor Company (Ford) is recalling certain model year 2015 Transit vehicles manufactured March 1, 2015, to April 10, 2015. The affected vehicles may have been built with seat belt assemblies that have seat belt labels that are missing the required belt model and model year and instead state "prototype sample." As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) 209, "Seat Belt Assemblies."
Keystone RV Company (Keystone) is recalling certain model year 2013 Montana trailers, models 3100RL, 3150RL13, 3400RL, 3402RL, 3582RL, 3625RE, 3725RL, 3750FL and 3900FB, manufactured November 12, 2012, to January 30, 2013, and 2014 Mountaineer trailers, models 331RLT, 356TBF and 375FLF, manufactured August 21, 2013, to September 18, 2013. In all models except the Mountaineer 375FLF, the rear windows are labeled with an exit sticker, but the rear window is not intended to be a secondary emergency exit. With the Mountaineer 375FLF, the rear window is intended as the secondary emergency exit, but it may be blocked by the rear ladder.
Shred-Tech Corporation (Shred-Tech) is recalling certain model year 2011-2013 MDS-20GT vehicles manufactured July 1, 2011, to March 1, 2013, 2010-2013 MDS-26GTX vehicles manufactured August 2, 2010, to March 1, 2013, 2013-2015 MDS 1/26 vehicles manufactured April 1, 2013, to May 1, 2015, and 2013-2015 MDS 2/26 vehicles manufactured March 1, 2015, to May 29, 2015. The affected vehicles were built on Hino 258LP and Freightliner M2 106 chassis and are equipped with EPA 2010 Emission Controls. With the EPA controls, the vehicles exceed the front axle Gross Axle Weight Rating (GAWR) specified on the certification label. As such, these vehicles fail to comply with the requirements of 49 CFR Part 567, "Certification."
Hyundai Motor America (Hyundai) is recalling certain model year 2015 Sonata vehicles manufactured April 25, 2014, to December 4, 2014. The affected vehicles have a front passenger seat belt whose buckle latch assembly may prevent the front passenger from fastening the seat belt.
Roadtrek Motorhomes Inc. (Roadtrek) is recalling certain model year 2014 170 Versatile, 190-Popular, 210-Popular, CS Adventurous, E-Trek, Ranger RT, RS Adventurous, SS Agile, and TS Adventurous vehicles manufactured September 18, 2013, to April 9, 2015 and built on a Mercedes-Benz Sprinter Chassis. The affected vehicles have electrical wiring connections under the front seats that can become dislodged or damaged and prevent the optional front seat SH9 Thorax air bags from deploying.
Oshkosh Corporation (Oshkosh) is recalling certain model year 2015 S-Series Front Discharge concrete mixer glider trucks manufactured February 10, 2015, to March 20, 2015. The affected vehicles have Allison HD4500 transmissions that were remanufactured by Valley Truck Parts that may be coated with a thick layer of paint on the torque converter to adaptation kit mounting surface which can soften during vehicle operation. This may result in the mounting bolts loosening.
Goshen Coach (Goshen) is recalling certain model year 2013-2015 Pacer, Pacer LS, Pacer LTD, GCII, Impulse, Connection, Commander, G-Force, G-Force Access, G-Force LTD, Sentinel, Sentinel UC, and Mainstream Low Floor buses manufactured August 26, 2013, to June 18, 2015. In the affected vehicles, the passenger seat belts may rub against the metal seat frame and fray. As a result, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 209, "Seat Belt Assemblies."
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration