Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns
Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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 the hazard involves a lack of assurance of sterility in an intravenous product, which poses a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Baxter Healthcare Corp. is recalling specific lots of 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack. The affected products are prescription-only intravenous solutions manufactured in Deerfield, IL. The recall involves 730,848 units distributed nationwide and in Puerto Rico.
The recall was initiated due to a lack of assurance of sterility. A manufacturing issue occurred during the sealing of the closure assembly at the administration port, which has been identified as a potential cause for leakage. This defect may compromise the sterile integrity of the product.
Healthcare providers and patients should check their inventory for the specific product codes and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not administered. Consumers should contact their healthcare provider for further instructions regarding the use of these specific lots.
The recalled product
- Product
- DEXTROSE (DEXTROSE MONOHYDRATE)
- Brand
- DEXTROSE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — IV Solution
- Affected units
- 730,848
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 (9)
- Lot #: a) Product code 2B0088: P280115
- P285239
- Exp 7/13
- b) Product code 2B0089: P280230
- P280461
- P285288
- P285288A
- P285783
- Exp 8/13
Distribution
Part of a larger recall action
This product is one of 6 recalled by Baxter Healthcare Corp. 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.
See all 6 products in this recall →Related recalls
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