Franck's Lab Recalls Ondansetron Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling 16 units of Ondansetron HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
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 and involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of infection or serious injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of 16 units of Ondansetron HCL injectable products. The affected products include various volumes of Ondansetron HCL, MDV 2mg/ml and Ondansetron HCL, P.F. 2mg/ml, distributed between November 21, 2011, and May 21, 2012.
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 these sterile products were prepared. The products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies.
Consumers and healthcare providers should stop using these products and contact their pharmacist or the recalling firm for further instructions. Specific prescription numbers associated with the recalled units are listed in the official recall documentation.
The recalled product
- Product
- ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 16
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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