Franck's Lab Recalls Sterile Intrathecal Bupivacaine and Morphine Sulfate Mixtures
Franck's Lab Inc. is recalling four sterile intrathecal drug mixtures because FDA sampling found microorganisms and fungal growth 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 the hazard involves a lack of assurance of sterility in intrathecal drugs, which carries a significant risk of serious injury or hospitalization due to infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling four sterile intrathecal drug products containing bupivacaine and morphine sulfate. The affected products are Bupivacaine/Morphine Sulfate, P.F. 2.5mg/10mg/ml Intrathecal 40 ml; Bupivacaine/Morphine Sulfate, P.F. 7.5mg/25mg/ml Intrathecal 20 ml; Bupivacaine/Morphine Sulfate, P.F. 7.5mg/50mg/ml Intrathecal 18 ml; and Bupivacaine/Morphine Sulfate, P.F. 7.5mg/50mg/ml Intrathecal 35 ml. The recall covers 16 units distributed between November 21, 2011, and May 21, 2012.
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 receiving the drugs.
The products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Specific prescription numbers associated with the recalled units are listed in the source data. Healthcare providers and patients should stop using these products and contact the manufacturer or FDA for further instructions.
The recalled product
- Product
- BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/50MG/ML INTRATHECAL 18 ML, 35 ML (4 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Intrathecal
- Affected units
- 16
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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