Baxter Sterile Water for Injection recalled due to manufacturing defects
McKesson is recalling Baxter Sterile Water for Injection USP (2000 mL) distributed nationwide due to temperature abuse during manufacturing that may compromise sterility.
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: FDA Class II recall of an intravenous injectable product due to temperature abuse during manufacturing, which may compromise product sterility. Although no reported illnesses or injuries exist, the risk posed to recipients of non-sterile injectables is significant, meeting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Sterile Water for Injection USP (2000 mL, NDC 0338-0013-06), manufactured by Baxter Healthcare Corp., due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
The recalled product was exposed to temperature abuse during manufacturing, which may have compromised its sterility assurance. Because this product is intended for intravenous injection, any compromise to sterility poses a risk of serious infection.
The recalled product was distributed nationwide in the United States. Because McKesson was unable to identify specific lot numbers for all recipients, separate notices were sent to each customer with information about their particular shipments.
Healthcare facilities and hospitals that received this product should immediately quarantine and stop use of any affected units. Consult McKesson or FDA resources for complete product identification details and detailed recall instructions.
The recalled product
- Product
- STERILE WATER (WATER)
- Brand
- STERILE WATER
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Sterile Injectable
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
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