Franck's Lab Recalls Pilocarpine Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling specific Pilocarpine HCL ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's 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 serious injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling three specific Pilocarpine HCL ophthalmic products. The affected items are Pilocarpine HCL P.F in B.S.S Ophthalmic 1% Injectable (36 mL), Pilocarpine HCL Solution 0.5% Ophthalmic (30 mL), and Pilocarpine HCL Solution (PF) 0.5% Ophthalmic (30 mL). The recall covers five units of these products.
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 sterile products were prepared. The recall applies to all sterile human drugs distributed by the company between November 21, 2011, and May 21, 2012.
The products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. The specific prescription numbers associated with the recall are 0407246, 0365303, and 0387896. Consumers should stop using these products and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS)
- Category
- Drug — Ophthalmic
- Affected units
- 5
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: 0407246 0365303 0387896
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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