Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers Recalled due to Mold Contamination

Risk Managers and Pharmacy healthcare personnel are informed by the FDA that Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers are recalled because a spore-like structured particulate, consistent with mold, was noted in the solution that may result in critical patient harm.

Background of Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers

Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers’ recall by Hospira Inc. is conducted as a precautionary measure.

FDA Alert on Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers

FDA’s reason for the recall is that, according to one confirmed customer report, a leak was identified in the primary Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Container between the cobra cap and fill-tube seal and a spore-like structured particulate, consistent with mold, was noted.

If the contaminated solution is used, this may result to critical patient harm leading to septicemia (blood stream infections), which may progress to life-threatening septic shock.

The affected lot is NDC #0409-7929-09, Batch# 12-160-JT* with expiration date December 1^st, 2013.

Recommendation on Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers

“Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-7688, between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.”

Contacting the FDA to report cases with Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers

In case of detection of adverse events or side effects related to the use of Hospira Lactated Ringer’s and 5% Dextrose Injection, 1000 Ml, Flexible Containers, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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