Bupivacaine HCL & Epinephrine Injectable (Franck's Lab) – Sterility Concern (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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% INJECTABL
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Rx #'s: 0402964 0402963 0398083 0398557 0398524 0406883 0396497 0401829 0407441 0408458 0408393 0398196 0398084 0405518 0397074 0401694 0401412 0398196 0404325 0397888 0407444 0408529 0408099 0401897 0402614 0405996 0402614 0405382 0398014 0398022 0400197 0400116 0400197 0401897 0405996 0398014 0402614 0398014 0401755 0401755 0404391 0402616 0401688 0398026 0399744 0402617 0398026 0401755 0398026 0402616 0400850 0404643 0408996 0403960 0400509 0400960 0403759 0404643 0405771
Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRI due to 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 . This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026