Franck's Lab Recalls Sterile Tetracaine Ophthalmic Solutions Due to Contamination
Franck's Lab Inc. is recalling sterile tetracaine ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where the drugs were prepared.
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 presence of microorganisms and fungal growth in a sterile drug manufacturing environment represents a significant risk of serious health consequences, such as infection, which aligns with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The recall includes three specific products: Tetracaine HCl Ophthalmic 0.05% Solution (3 mL and 6 mL) and Tetracaine HCl P.F. Ophthalmic 0.5% Solution (30 mL). A total of 26 units are affected.
The recall was initiated after 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 using the medications.
The affected products were distributed nationwide as well as in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic
- Affected units
- 26
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 98 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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