Franck's Lab Recalls Sterile Vanadyl Sulfate Injectable Due to Contamination
Franck's Lab Inc. is recalling sterile Vanadyl Sulfate Solution injectable because FDA sampling found microorganisms and fungal growth in the preparation clean room.
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 all sterile human drugs distributed between November 21, 2011, and May 21, 2012. The specific product identified in the recall notice is Vanadyl Sulfate Solution 200mcg/ml Injectable, 60 ml. The recall was triggered by FDA environmental sampling that revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared.
The recalled products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. The recall is classified as Class II by the FDA. The source text does not report any specific illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the recalled sterile human drugs and contact their pharmacist or the recalling firm for further instructions. The recall number is D-1637-2012.
The recalled product
- Product
- VANADYL SULFATE SOLUTION 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
- Category
- Drug — Sterile Injectable
- Affected units
- 1
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: 0402124
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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