FDAClass IIMarch 8, 2023

Sterile Water for Injection recall: CGMP Deviations

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

Why was Sterile Water for Injection recalled?

CGMP Deviations: Potential product carryover.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023

Product
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
Recalling firm
Nephron Sc Inc
Quantity
325,080 vials
Distribution
United States
Recall date
March 8, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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