Franck's Lab Recalls Sterile Metoclopramide Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile metoclopramide HCL injectable products 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 and involves sterile injectable drugs contaminated with microorganisms and fungal growth, which poses a significant risk of serious injury or infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific products involved are metoclopramide HCL 5mg/ml (10mg/2ml) injectable in various sizes, including 2 ml, 20 ml, 200 ml, 394 ml, 400 ml, 498 ml, 500 ml, 6 ml, and 600 ml.
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 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 guidance. The recall covers 13 units of the specified metoclopramide HCL injectable products.
The recalled product
- Product
- METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 2 ML 20 ML 200 ML 394 ML 400 ML 498 ML 500 ML 6 ML 600 ML (9 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 13
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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