US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 25, 2012 (14 years ago)

Fentanyl, P.F. 100mcg/Ml Injectable 12 Ml, 2 Ml, 30 Ml, 60 Ml; Fentanyl, P.F. 50mcg/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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

What was recalled

FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)

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-1518-2012

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 Fentanyl recalls

See all