Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic drugs 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, and the hazard involves a lack of assurance of sterility in ophthalmic products, which carries a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific product identified in the recall notice is CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% Ophthalmic 20 ML.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility poses a risk of infection to patients using the products.
The affected products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. The specific prescription number associated with the product is 0392313. Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)
- Category
- Drug — Sterile 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 #: 0392313
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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