Sterile Water for Injection recall: CGMP Deviations
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
Why was Sterile Water for Injection recalled?
CGMP Deviations: potential for trace amounts of 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?
Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
- Product
- Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.
- Recalling firm
- Nephron Sc Inc
- Quantity
- 389,730 vials
- Distribution
- Nationwide in the USA
- Recall date
- February 1, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)