Pfizer 5% Dextrose Injection Recalled for Potential Bag Leakage
Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.
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: This is an FDA Class II recall involving a sterility defect in an intravenous injection product. Lack of sterility assurance and potential bag leakage in an injectable pharmaceutical present significant risk of harm through contamination or compromised product integrity, meeting the Severe threshold even though no illnesses or injuries are reported in the source text.
Plain-English summary
Pfizer Inc. is recalling Lot 4923608 of 5% Dextrose Injection, USP (50 mL ADD-Vantage Units, NDC 0409-7100-68/0409-7100-66) with an expiration date of May 1, 2022. The reason for the recall is lack of sterility assurance; the bags have the potential to leak.
A total of 765 bags were distributed nationwide in the USA. Healthcare providers and patients who have received this product should check their inventory for the affected lot number and expiration date.
Patients using this product should consult their healthcare provider if they have any concerns. Healthcare facilities should review their stock of this medication and quarantine any units from the affected lot pending further instructions from Pfizer.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Pfizer Inc.
- Affected units
- 765
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: 4923608 Exp. 1MAY2022
Distribution
Distributed nationwide across the United States.
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