Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia,
Summary
The FDA issued a Class II for Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 45 by Nephron Sc Inc. Reason: CGMP Deviations: Potential product carryover..
Details
Source
Drug Recall
External ID
D-0364-2023
Action Date
2023-03-08
Status
Terminated
Category
drug
Product Description
Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron 4500 12th Street Extension West Columbia, SC 29172, NDC 0487-6105-01
Lot/Code Info: Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Quantity Affected: 325,080 vials
Reason for Recall
CGMP Deviations: Potential product carryover.
Distribution
United States
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-23
Company
West Columbia, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Nephron Sc Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nephron Sc Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nephron Sc Inc have FDA actions?
Nephron Sc Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0364-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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