Agency classClass IIOur severity:Severe FDA (Drugs)·D-1470-2012·Announced 2012-08-22

Franck's Lab Recalls Sterile Bupivacaine Injectable Drugs Due to Sterility Concerns

Franck's Lab Inc. is recalling sterile bupivacaine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in injectable drugs, which carries a significant risk of serious injury or death from infection.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall involves 79 units of various bupivacaine HCL and bupivacaine HCL with epinephrine injectable products in multiple concentrations and volumes.

The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This lack of assurance of sterility poses a risk of contamination to the affected drugs.

The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

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…
Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category: Drug — Injectable Sterile Drugs
Hazard: microbial-contamination
fungal-growth
sterility-failure
Affected units: 79

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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