Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
What this means for you
Illness, injury, or structural failure has been reported. 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 microbial and fungal contamination of sterile ophthalmic solutions, which 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, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific products involved are Tropicamide/Phenylephrine Ophthalmic 15:1 Solution in various volumes, including 90 ml, 128 ml, 480 ml, 496 ml, and 576 ml. The recall was initiated due to a lack of assurance of sterility.
The FDA conducted environmental sampling in the clean room where these sterile products were prepared. The sampling revealed the presence of microorganisms and fungal growth. This contamination raises concerns about the sterility of the affected ophthalmic solutions.
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 healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TROPICAMIDE/PHENYLEPHRINE OPHTHALMIC 15:1 SOLUTION 128 ML 480 ML 496 ML 576 ML 90 ML (5 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic
- 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 (1)
- Rx #'s: 0394909 0394909 0394909 0394909 0394909
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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