Gibco Dulbecco's Modified Eagle Medium recalled over sterility concerns

Recall date

May 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Life Technologies, Corp. recalls Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture m…

Recall number

Z-2544-2018

FDA classification

Class II

Brand / firm

Life Technologies, Corp.

Sold / distributed

Worldwide distribution. US states: CA, CO, CT, FL, GA, MA, MD, PA, RI, UT, and WA., Canada, France, Great Britain, Japan, Korea, Netherlands, and Switzerland.

Why it was recalled

It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.