Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or in this case, a structural failure of sterility assurance leading to potential serious harm, align with a Severe rating (Score 4).
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 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. The specific product identified in the recall notice is LISSAMINE GREEN SOLUTION 1% OPHTHALMIC, 10 ML.
The recalled products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
- Category
- Drug — Ophthalmic
- Affected units
- 1
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 #: 0391580
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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