Labetalol Hydrochloride Injectable Recalled for Sterility Assurance Issues
Franck's Lab Inc. is recalling Labetalol Hydrochloride 5mg/mL injectable products due to microorganisms and fungal growth found in the 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 serious injury or death from infection.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling Labetalol Hydrochloride 5mg/mL Injectable products in 100 mL and 80 mL volumes. 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 indicates a lack of assurance of sterility for the affected products.
The affected products were distributed nationwide and in the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies. 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
- LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE 100 ML 80 ML (2 DIFFERENT PRODUCTS)
- Category
- Drug — Injectable
- Hazard
- 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: 0386748 0389778
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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