US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 21, 2012 (14 years ago)

Paclitaxel 6mg/Ml Injectable 500 Ml

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

PACLITAXEL 6MG/ML INJECTABLE 500 ML (1 PRODUCT)

Recalling firm
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1591-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Paclitaxel recalls

See all
Class II · Moderate risk Terminated

Paclitaxel Semi-Synthetic active pharmaceutical ingredient…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Attix Pharmaceuticals D-829-2015
Class III · Low risk Terminated

Paclitaxel Injection

Reason Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.

Fresenius Kabi USA, LLC NDC 63323-763-50 D-016-2014