Franck's Lab Recalls Sterile Bupivacaine/Sufentanil Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile bupivacaine/sufentanil injections because FDA sampling found microorganisms and fungal growth in the production clean room.
What this means for you
Illness, injury, or structural failure has been reported. 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 involves a lack of assurance of sterility in intrathecal injections, which poses a significant risk of serious injury or death from infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific product identified is Bupivacaine/Sufentanil, P.F. 15mg/150mcg/ml Intrathecal 20 ml. 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.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. The recall covers 2 units of the product.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/ML INTRATHECAL 20 ML (1 PRODUCT)
- Category
- Drug — Sterile Injectables
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Rx #:N0390025 N0399831
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.
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