Agency classClass IIOur severity:Severe FDA (Drugs)·D-1563-2012·Announced 2012-08-22

Franck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns

Franck's Lab Inc. is recalling Lidocaine/Tetracaine Ophthalmic Solution because FDA testing found microorganisms and fungal growth in the clean room where the sterile 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 and involves a lack of assurance of sterility in ophthalmic products, which poses a significant risk of infection and potential serious injury.

Plain-English summary

Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling Lidocaine/Tetracaine Ophthalmic 4%/0.5% Solution in various sizes (10 ml, 15 ml, 20 ml, 200 ml, 240 ml, 300 ml, and 400 ml). The recall covers all sterile human drugs distributed between November 21, 2011, and May 21, 2012.

The recall was initiated due to a lack of assurance of sterility. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. The affected products were distributed nationwide and to several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on appropriate alternatives. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)
Manufacturer: Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Category: Drug — Ophthalmic
Hazard: microbial-contamination
fungal-growth
sterility-failure
Affected units: 8

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.

See all 98 products in this recall →

Same manufacturer · Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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Same hazard · microbial contamination