Pfizer Recalls LMD in Dextrose Bags Due to Sterility Concerns
Pfizer is recalling 17,832 bags of LMD in Dextrose Injection due to a potential leak that compromises sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (intravenous drug) where injury has not yet been reported, fitting the 'High' severity criteria for potential contamination without confirmed illness.
Plain-English summary
Pfizer Inc. is recalling 17,832 bags of LMD in Dextrose (Dextran 40) Injection, USP. The product is a prescription-only intravenous solution distributed nationwide in the United States and Puerto Rico. The specific lot affected is 87-095-JT with an expiration date of March 1, 2020.
The recall was initiated because the bags have the potential to leak, which creates a lack of assurance of sterility. This defect poses a risk of contamination to the intravenous solution.
Healthcare providers and facilities should check their inventory for this specific lot number and expiration date. Patients who have received this product should contact their healthcare provider for guidance.
The recalled product
- Product
- LMD IN DEXTROSE (DEXTRAN 40)
- Brand
- LMD IN DEXTROSE
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Intravenous Solution
- Affected units
- 17,832
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)
- Lot #: 87-095-JT Exp. 1MAR2020
Distribution
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