Cipro & Flagyl Recall!

[Guest guest]

One Company recalling Ciprofloxacin & Metronidazole (Flagyl) injections

voluntarily supposedly because of " floating particles " ??? Just wonder how

many " healthcare "

people who get this Recall (as with the many Black Box Warnings) actually

Pay Attention to it?!

*******

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market

withdrawals

from the firms involved as a service to consumers, the media, and other

interested parties. FDA does not endorse either the product or the

company.

Claris Lifesciences initiates a nationwide voluntary recall of all lots of

Ciprofloxacin Inj. USP 200 mg / 100 mL, Ciprofloxacin Inj. USP 400 mg /

200 mL,

Metronidazole Inj. USP 500 mg/100 ml and Ondansetron Inj., 32 mg / 50 mL.

FOR IMMEDIATE RELEASE - June 1, 2010 - Claris Lifesciences today announces

the voluntary nationwide recall of all lots of Ciprofloxacin Inj. USP 200

mg / 100

mL (NDC 36000-008-24), Ciprofloxacin Inj. USP 400 mg / 200 mL (NDC

36000-009-24), Metronidazole Inj. USP 500 mg/100 ml (NDC 36000-001-24), and

Ondansetron in 5% Dextrose Inj. 32 mg / 50 mL (36000-014-06) manufactured

and

distributed by Claris Lifesciences. All lots are being recalled, which were

distributed to hospitals, wholesalers and distributors nationwide.

Claris has initiated this voluntary recall of the product listed above to

the

user level as a precautionary measure against possible contamination due to

packaging integrity of the product. Claris is initiating a voluntary

recall of

the products listed above because it has received reports of floating

matter

which may pose risk if administered to patients. Healthcare professionals

should

NOT use these products, and should immediately remove them from their

pharmacy inventories. This recall is made with the full knowledge of the Food

and Drug Administration. Claris is not aware of any adverse patient events

resulting from this product and is continuing its diligent investigation of

the situation.

Customers have been instructed to examine their inventory immediately and

to

quarantine, discontinue distribution of and return all recalled lots of the

product. Customers who may have further distributed this product have been

requested to identify their customers and notify them at once of this

product

recall. The necessary form by which to document this information as well as

other information regarding this recall is available at

_http://www.clarislifesciences.com/Claris_USA/index.asp1._

(http://www.clarislifesciences.com/Claris_USA/index.asp1.)

Any questions about returning unused product should be directed to the

customer call center at +1 (877) 725- 2747, M-F 8am-7pm CST. Healthcare

workers who have medical questions about the products may contact the same

number

and ask for Medical affairs.

Any adverse events that may be related to the use of this product should be

reported at Claris customer helpline number at 1-877-725-2747, FDA's Med

Watch

Program by fax at 1-800-FDA-0178 or by mail at MEDWATCH, HF-2, FDA, 5600

Fishers Lane, Rockville, MD 20852-9787 or on the Medwatch website at

_www.fda.gov/safety/medwatch/default.htm2_

(http://www.fda.gov/safety/medwatch/default.htm2) .