Heparin Sodium Injectable Recall Due to Sterility Assurance Failure
Franck's Lab Inc. is recalling heparin sodium injectables because FDA sampling found microorganisms and fungal growth in the clean room where sterile 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance 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, is recalling specific lots of Heparin Sodium and Heparin Lock Sodium injectable products. The recall covers products distributed between November 21, 2011, and May 21, 2012. The affected products include various concentrations and volumes of heparin sodium and heparin lock sodium, totaling 12 units.
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 drugs.
The products were distributed nationwide as well as to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT…
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 12
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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