Franck's Lab Recalls Levothyroxine Sodium Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Levothyroxine Sodium Injectable due to microorganisms and fungal growth found 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 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 and potential serious injury.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling Levothyroxine Sodium 325mcg/ml (0.325mg/ml) Injectable, 15 mL. The recall covers all sterile human drugs distributed between November 21, 2011, and May 21, 2012.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. This lack of assurance of sterility poses a risk to patients using the medication.
The affected products were distributed nationwide and to the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- LEVOTHYROXINE SODIUM 325MCG/ML (0.325MG/ML) INJECTABLE 15 ML (1 PRODUCT)
- Category
- Drug — Injectable Sterile Drug
- Affected units
- 2
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: 0370408 0408889
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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