Franck's Lab Recalls Sterile Hydromorphone/Clonidine Intrathecal Drugs
Franck's Lab Inc. is recalling specific sterile hydromorphone/clonidine intrathecal drugs 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, and the hazard involves a lack of sterility assurance in intrathecal drugs, which carries a significant risk of serious injury or hospitalization from infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling three specific sterile hydromorphone/clonidine intrathecal products. The affected products are Hydromorphone/Clonidine P.F. 120mg/1.3mcg/ml, 120mg/1.8mcg/ml, and 80mg/1.2mcg/ml, each in 10 ml vials. A total of 7 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 the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies between November 21, 2011, and May 21, 2012. Patients and healthcare providers should contact their prescriber or pharmacist for instructions on how to manage the recall and obtain alternative treatment if necessary.
The recalled product
- Product
- HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Sterile Compounded Drug
- Affected units
- 7
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 #'s:N0395798 N0397394 N0392201 N0400799 N0403781 N0407180 N0390189
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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