Franck's Lab Recalls Povidone-Iodine Ophthalmic Solutions Due to Sterility Concerns
Franck's Lab Inc. is recalling specific povidone-iodine ophthalmic solutions 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, which corresponds to a Severe rating under the rubric for potential serious, reversible health consequences.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 18 units of Povidone-Iodine Ophthalmic 5% Solution and Povidone-Iodine, Buffered in BSS 4.6% Ophthalmic. The affected products were distributed between November 21, 2011, and May 21, 2012, to locations including the United States, the Bahamas, Colombia, the 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 firm during the specified period.
Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for instructions on return or replacement. The specific prescription numbers associated with the recalled units are 0387489, 0387820, 0401069, 0393386, and 0374184.
The recalled product
- Product
- POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic Solution
- Affected units
- 18
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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