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

Bupivacaine HCL & Epinephrine

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

BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL 0.25% INJECTABLE 120 ML,180 ML, 240 ML, 250 ML, 300 ML, 500 ML, 60 ML; BUPIVACAINE HCL 0.5% INJECTABLE1000 ML, 120 ML, 200 ML, 250 ML, 400 ML, 50 ML, 500 ML, 600 ML, 750 ML; BUPIVACAINE HCL, P.F. 0.25% INJECTABLE 1000 ML, 120 ML, 1200 ML, 150 ML, 1500 ML, 180 ML, 240 ML, 300 ML, 60 ML, 600 ML, 900 ML; BUPIVACAINE HCL, P.F. 0.5% INJECTABLE 10 ML, 120 ML, 1500 ML, 20 ML, 200 ML, 240 ML, 2500 ML, 300 ML, 360 ML, 600 ML, 960 ML; BUPIVACAINE HCL, P.F. 0.75% INJECTABLE 1200 ML, 150 ML, 240 ML, 30 ML, 600 ML, 7 ML (47 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-1470-2012

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 Bupivacaine recalls

See all
Class II · Moderate risk Ongoing

BUPIVAcaine HCL Sterile injection

Reason Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Tailstorm Health INC NDC 81483-0036-0 D-0499-2025
Class II · Moderate risk Terminated

fentaNYL 500 mcg/100 mL

Reason Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC NDC 70004-0251-64 D-0401-2024