Franck's Lab Recalls Riboflavin Ophthalmic Solutions Due to Sterility Concerns
Franck's Lab Inc. is recalling specific riboflavin ophthalmic solutions because FDA testing found microorganisms in the production 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 and involves a lack of assurance of sterility in ophthalmic products, which poses a significant risk of infection and potential hospitalization.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of three specific riboflavin ophthalmic solution products. The affected items are Riboflavin Solution 0.1% Ophthalmic in 10 mL and 5 mL sizes, and Riboflavin Solution, P.F. 0.1% Ophthalmic in 90 mL size. These 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.
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 recall covers all sterile human drugs distributed by the company between November 21, 2011, and May 21, 2012.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions. The specific prescription numbers associated with the recalled units are 0400853 and 0386510.
The recalled product
- Product
- RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic
- Affected units
- 3
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: 0400853 0400853 0386510
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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