Daily Archives: February 25, 2015

Heritage Pharmaceuticals Initiates a Nationwide Voluntary Recall of Colistimethate for Injection

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Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers with expiry date being recalled are: Colistimethate for Injection

Lot No.
VCOA002
VCOA003
VCOA004
VCOA005
VCOA006
VCOA007
VCOA008
VCOA009
VCOA010
VCOA011		 Exp. Date
9/30/2014
10/31/2014
10/31/2014
1/31/2015
3/31/2015
9/30/2015
12/31/2015
2/29/2016
10/31/2016
10/31/2016

Rifampin for Injection

Lot No.
VRIA002
VRIA003
VRIA004		 Exp. Date
8/31/2016
9/30/2016
9/30/2016

The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (Colistimethate) and from October 2014 through January 2015 (Rifampin). Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is indicated for the treatment of all forms of tuberculosis.

Customers are being notified by fax, email, UPS, and/or certified mail that includes arrangements for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of, and return the recalled lots of product. Customers who may have further distributed these products have been requested to identify their customers and notify them at once of this product recall.

Any questions about returning unused product should be directed to the customer call center at (866) 901-1230 M-F 9am-5pm EST. Healthcare workers who have medical questions about Colistimethate for Injection, USP, 150 mg base/vial and Rifampin for Injection USP, 600 mg/vial may contact Heritage Medical Affairs (732-429-1000, Ext. 101) M-F 9am-5pm EST.

Fiber line cut near Carefree causes massive Internet and phone outage in Northern Arizona

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PHOENIX – Northern Arizona lost phone, Internet and television due to a fiber line that was cut near Carefree, Arizona. The outage affected from Page to Williams.

Channel 3 in Phoenix reported that Century Link officials confirmed that a fiber line that was deliberately cut caused the outage. The cut line caused outage of communications from about 11:30 a.m. until about 6 p.m. Other Internet and service providers using the line were also affected.

911 calls were immediately re-routed through another line.

Officials are still investigating the incident.

Archaeology Comes Alive on the Kaibab

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WILLIAMS –  Two free Archaeology Month evening lectures will be held at  6:30 PM at the Mills 326 Café, 326 West Route 66, Williams, Arizona. There is limited seating so please call 928-635-5600 for reservations. To order food ahead of time call, 928-635-0777.
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  • March 5: (Williams and Tusayan Ranger District Archaeologist Neil Weintraub) –Williams Youth Conservation Corps: Getting’ Dirty Preserving Kaibab National Forest Historic Sites. This presentation will discuss the history of how the Williams Youth Conservation Corps has helped to protect and enhance dozens of prehistoric and historic archaeological sites on the Williams Ranger District.
  • March 19: (Kaibab National Forest Archaeologist Margaret Hangan and Neil Weintraub) – History of Kaibab National Forest Managed Fires and Cultural Resource Protection Efforts during the Summer 2014 Sitgreaves Fire. For the past decade when conditions are appropriate during monsoon season, the Kaibab National Forest fire staff has managed wild fires across large portions of its fire adapted landscape. Archaeologists will discuss how Kaibab National Forest fire staff managed the summer 2014 Sitgreaves Fire to treat a steep mountain landscape while protecting and reducing fuels on dozens of significant cultural resources.

Kaibab archaeologists will also lead free educational hikes to the Keyhole Sink Petroglyph site at 2 PM on March 14 and March 28. Please call ahead for reservations, 928-635-5600.
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Bring boots and warm clothing as this 3/4-mile hike each way will take place whether there is rain, snow or sun. Be prepared to get wet as a waterfall often cascades off the lava flow requiring crossings in ankle deep water to access the petroglyphs.

To attend, meet at the Oak Hill Snow Play area, 4 miles west of Parks Arizona on the south side of Route 66. From Flagstaff, take I-40 west to exit 178, turn right at top of ramp and then left on to Route 66. Drive about 4 miles west to the Oak Hill Snow Play Area.

From Williams, drive east on I-40 to Exit 171 and at top of off ramp make a right and then another right onto Route 66. Drive east on 66 about 2 miles to the Oak Hill Snow Play Area.

Lectures are Wheelchair Accessible; petroglyphs are not.