Franck's Lab Recalls Sterile Intrathecal Baclofen and Hydromorphone Mixtures
Franck's Lab Inc. is recalling sterile intrathecal drug mixtures due to microorganisms and fungal growth found in the clean room.
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. The hazard involves the lack of assurance of sterility in intrathecal drugs, which carries a high risk of serious injury or death if administered, fitting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling specific sterile intrathecal drug products containing baclofen and hydromorphone. The affected products include three specific concentrations and volumes: 2000mcg/2.9mg/ml in 20 ml, 2000mcg/6mg/ml in 40 ml, and 500mcg/50mg/ml in 40 ml. A total of 6 units were distributed.
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 to patients receiving these intrathecal injections. The products were distributed nationwide and to several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies.
Healthcare providers and patients should stop using these products immediately. The recall covers all sterile human drugs distributed by the firm between November 21, 2011, and May 21, 2012. Specific prescription numbers associated with the recall are N0407992, N0387607, N0394440, N0402003, N0409979, and N0399632.
The recalled product
- Product
- BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS)
- Affected units
- 6
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 (6)
- Rx #'s:N0407992
- N0387607
- N0394440
- N0402003
- N0409979
- N0399632
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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