Franck's Lab Recalls Cisplatin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility failure in injectable drugs) are categorized as Severe.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, has initiated a recall of Cisplatin 1mg/ml Injectable products in 1000 ml and 2000 ml sizes. The recall covers all sterile human drugs distributed by the company between November 21, 2011, and May 21, 2012. The affected products were distributed nationwide and in several international locations, including the Bahamas, Colombia, 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 sterile products were prepared. This finding indicates a lack of assurance of sterility for the affected drugs. The specific prescription numbers associated with the recalled units are 0392538, 0391562, and 0391564.
Patients who have received these products should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable
- Affected units
- 3
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: 0392538 0391562 0391564
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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