Infuvite Adult Multiple Vitamins Injection Recalled for Storage Deviation
Baxter Healthcare's Infuvite Adult Multiple Vitamins Injection is being recalled because 70 vials were stored outside their labeled specifications, potentially affecting product stability. The affected vials were distributed to three direct accounts in Arizona, New Mexico, and Utah.
What this means for you
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: This is an FDA Class II recall involving storage deviation with no reported illnesses or injuries. The hazard is storage-related rather than contamination or an inherent product defect. Without evidence of adverse health consequences, the severity is rated High per the rubric.
Plain-English summary
Infuvite Adult Multiple Vitamins Injection, manufactured by Baxter Healthcare Corp. and distributed by Mckesson Medical-Surgical Inc., is being recalled. The recall involves 70 vials of the 5 mL single-dose injection (NDC 54643-5649-01, code 519644).
The products were stored outside the drug label specifications, constituting a deviation from current Good Manufacturing Practice (cGMP) standards. Improper storage conditions can affect the stability and efficacy of injectable vitamin products.
The recalled vials were distributed to three direct accounts located in Arizona, New Mexico, and Utah.
Healthcare providers and facilities receiving this recall notification should verify whether they have the affected vials and take appropriate action based on guidance from the FDA and the recalling manufacturer.
The recalled product
- Product
- Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Vitamins
- Hazard
- gmp-deviation
- improper-storage
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)
- 519644
Distribution
Distributed in 3 states:
- AZ
- NM
- UT
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