Franck's Lab Recalls Sterile Hyaluronidase and Lidocaine Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile hyaluronidase and lidocaine injectables because FDA sampling found microorganisms and fungal growth in the clean room where the products 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 the hazard involves a lack of assurance of sterility in injectable drugs, which poses a significant risk of serious injury or infection.
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 products involved are Hyaluronidase / Lidocaine 7.1U/9.5mg/mL Injectable in 105 mL and 210 mL volumes, comprising six different products. A total of 17 units were distributed.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where these sterile products were prepared. This finding indicates a lack of assurance of sterility for the affected products.
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. Affected prescription numbers include 0359944 and 0408186. Consumers and healthcare providers should stop using these products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- HYALURONIDASE / LIDOCAINE 7.1U/9.5MG/ML INJECTABLE 105 ML, 210 ML (6 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable
- Affected units
- 17
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: 0359944 0359944 0408186
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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