Sterile water injection vials recalled for trace product carryover risk
Nephron Pharmaceuticals recalls approximately 389,730 vials of sterile water for injection nationwide due to potential product carryover from manufacturing deviations. No illnesses have been reported.
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 with no reported illnesses or injuries. The hazard—potential product carryover in a sterile injectable product—represents a theoretical contamination risk in a critical-use drug. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring at the High level.
Plain-English summary
Nephron Pharmaceuticals Corporation is recalling Sterile Water for Injection, USP, for drug diluent use. The recall affects approximately 389,730 single-dose vials (5 mL each, packaged in cartons of 30) distributed nationwide in the United States. The recall was initiated due to potential for trace amounts of product carryover identified during a review of manufacturing processes.
The affected lots are: 124081 and 124082 (expiration 04/2023) and lot 224031 (expiration 01/2024). The product is identified by NDC 0487-6105-01 and UPC 3 04876 10501 3.
No illnesses or adverse events have been reported to date. Healthcare professionals should stop dispensing affected lots and notify patients who may have received them. Patients should consult their healthcare provider if they have questions about their medication. Unused vials should be returned to the pharmacy or manufacturer.
The recalled product
- Product
- STERILE WATER (STERILE WATER)
- Brand
- STERILE WATER
- Manufacturer
- Nephron Sc Inc
- Category
- Drug — Sterile Injectable
- Hazard
- product-carryover
- contamination
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 (5)
- Lots: 124081
- 124082
- Exp. 04/2023
- 224031
- Exp. 01/2024
UPCs (2)
- 0304876105013
- 304876105013
Distribution
Distributed nationwide across the United States.
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