Franck's Lab Recalls Sterile Papaverine and Alprostadil Injectable Drugs
Franck's Lab Inc. is recalling sterile papaverine and alprostadil injectables distributed between November 2011 and May 2012 due to microbial contamination found 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 involves sterile injectable drugs with confirmed microbial and fungal contamination, posing 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 two sterile injectable drug products: Papaverine/Alprostadil 30mg/10mcg/ml and Papaverine/Alprostadil 30mg/15mcg/ml. The recall covers all units distributed between November 21, 2011, and May 21, 2012. The products were distributed nationwide and in several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
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 indicates a lack of assurance of sterility for the affected drugs.
Patients and healthcare providers who have received these specific products should contact their healthcare provider for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PAPAVERINE/ALPROSTADIL 30MG/10MCG/ML INJECTABLE 10 ML; PAPAVERINE/ALPROSTADIL 30MG/15MCG/ML INJECTABLE 10 ML (2 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 2
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: 0406632 0390375
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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