Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's 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, and the presence of microorganisms and fungal growth in a sterile product manufacturing environment poses a significant risk of serious health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of four specific glycerin ophthalmic products. The affected items are Glycerin 99.5% Ophthalmic (10 ml, 5 ml, and 7.5 ml) and Glycerin 100% Ophthalmic (15 ml). These products were distributed nationwide and internationally to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies between November 21, 2011, and May 21, 2012.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This finding indicates a lack of assurance of sterility for the affected batches.
Consumers and healthcare providers should stop using these products immediately. The specific prescription numbers associated with the recalled units are 0405776, 0405779, 0393390, and 0405545. Patients should consult their healthcare provider for alternative treatments or further guidance.
The recalled product
- Product
- GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic
- Affected units
- 4
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: 0405776 0405779 0393390 0405545
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 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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