FDA Auto Injector Recall

 

The following recall is from the FDA enforcement report.  Complete details can be found at http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm190285.htm

 

PRODUCT

Twinject 0.3 mg Auto-Injector (epinephrine injection, USP 1:1000), Rx only, NDC 59630-802-01. Note that this lot of Twinject is labeled with the previous owner, Verus Pharmaceuticals', NDC # 13436-700-01. Recall # D-031-2010
CODE
Lot U081008A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sciele Pharma, Inc., Atlanta, GA, by letter on/about September 23, 2009.
Manufacturer: Philips Plastics, Corp., Menomonie, WI. Firm initiated recall is ongoing.
REASON
Defective Delivery System; High Force-To-Fire values for the 12 month pull performance testing of Twinject 2008 annual stability units.
VOLUME OF PRODUCT IN COMMERCE
5,988 units
DISTRIBUTION
AZ, CA, CO, CT, FL, LA, NC, OH, PA, SC, TX, WA, and WI

 

 

 

 

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