Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Hydromorphone Mixtures
Franck's Lab Inc. is recalling six sterile intrathecal drug mixtures due to microbial contamination found in the clean room where they were prepared.
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 sterile intrathecal drugs with confirmed microbial and fungal contamination, which poses a significant risk of serious infection or injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of six sterile intrathecal drug products containing bupivacaine and hydromorphone. The affected products include various concentrations and volumes, such as 15mg/40mg/ml in 40ml vials and 7.5mg/20mg/ml in 40ml vials. A total of 15 units were distributed nationwide and to several international locations, including the Bahamas, Colombia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
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 infection to patients who receive these intrathecal injections. The distribution period for the recalled products was between November 21, 2011, and May 21, 2012.
Healthcare providers and patients should stop using the affected products immediately. Patients who have received these injections should contact their healthcare provider for evaluation. The recall covers specific prescription numbers listed in the official notice, including N0408787, N0390587, and others.
The recalled product
- Product
- BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/20MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 7.5MG/25MG/ML INTRATHECAL 18 ML; BUPIVACAINE/HYDROMORPH
- Affected units
- 15
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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