Franck's Lab Recalls Moxifloxacin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Moxifloxacin injectable products because FDA sampling found microorganisms 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 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 Moxifloxacin 150mcg/0.1ml (1.5mg/ml) Injectable products in 10 ml and 20 ml vials. The recall covers six units of these sterile human drugs that were 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 affected 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 the recalled Moxifloxacin injectable products and contact their healthcare provider or pharmacist for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- MOXIFLOXACIN 150MCG/0.1ML (1.5MG/ML) INJECTABLE 10 ML 20 ML (2 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 6
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: 0384231 0384231
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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