Sterile Water for Injection Recalled Due to Manufacturing Quality Deviations
Nephron Sc Inc recalls 325,080 vials of Sterile Water for Injection due to manufacturing quality deviations that could result in product carryover. Affected lots expire December 31, 2023.
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 with manufacturing quality deviations creating potential product carryover. No reported illnesses or adverse events. The theoretical hazard in an injectable pharmaceutical product warrants High severity.
Plain-English summary
Nephron Sc Inc is recalling 325,080 vials of Sterile Water for Injection, USP, in 30 mL single-dose vials (NDC 0487-6105-01) distributed throughout the United States.
The recall is being issued due to good manufacturing practice (CGMP) deviations that create the potential for product carryover. Sterile Water for Injection is used for intravenous, intramuscular, and subcutaneous administration.
The recalled lots are 224011, 224021, 224022, and 224023, all with expiration dates of December 31, 2023. Healthcare facilities and consumers with these lots should identify and isolate them immediately.
If you have received these lots, do not use the product. Contact Nephron Sc Inc or your healthcare provider for replacement product or instructions on returning the recalled vials.
The recalled product
- Product
- STERILE WATER (STERILE WATER)
- Brand
- STERILE WATER
- Manufacturer
- Nephron Sc Inc
- Hazard
- product-carryover
- manufacturing-deviation
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 (4)
- Lot #: 224011
- 224021
- 224022
- 224023 Exp 12/31/2023
UPCs (1)
- 0304876105013
Distribution
Distribution scope not specified by the agency.
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