Franck's Lab Recalls Budesonide Nasal Irrigation Due to Sterility Concerns
Franck's Lab Inc. is recalling two units of Budesonide nasal irrigation solution because FDA testing found microorganisms in the production 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 presence of microorganisms and fungal growth in a sterile product poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of specific Budesonide nasal irrigation solutions. The affected products are Budesonide (P.F) Nasal Irrigation 0.5mg/500ml Solution (1000 ml) and Budesonide (P.F) Nasal Irrigation 0.6mg/50ml Solution (1500 ml). The recall covers two different units associated with prescription numbers 0390774 and 0392517.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This finding indicates a lack of assurance of sterility for the products distributed during the period from November 21, 2011, to May 21, 2012.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Consumers who possess these specific prescription numbers should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining a replacement.
The recalled product
- Product
- BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFERENT UNITS)
- Category
- Drug — Sterile Compounded Drug
- 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 (2)
- Rx #'s: 0390774
- 0392517
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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