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

FDA recall notice · announced March 8, 2023 · Nephron Sc

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

CGMP Deviations: Potential product carryover.

Notes

Distribution: United States
Lot/code information: Lot #: 224011, 224021, 224022, 224023 Exp 12/31/2023
Quantity: 325,080 vials
Status: Terminated
Products in this recall event:
- 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 (D-0364-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.