Franck's Lab Recalls Sterile Papaverine HCL Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile Papaverine HCL injectable vials because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile injectable drugs.
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 products identified in the recall notice are Papaverine HCL 30mg/mL injectable vials in 10 mL and 100 mL sizes.
The recall was initiated after 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 products.
The affected products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients who have received these products should contact their healthcare provider for further instructions.
The recalled product
- Product
- PAPAVERINE HCL **(10ML VIAL) 30MG/ML INJECTABLE 10 ML 100 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: 0402993 0394666
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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