Multi-event January 2023 FDA Recall Sodium Chloride by Nephron Sc Inc
This Multi-event Class II drug recall was voluntarily initiated by Nephron Sc Inc on January 12, 2023 for the product Sodium Chloride. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0178-2023
CGMP Deviations: potential for trace amounts of product carryover.
01-12-2023
02-01-2023
389,730 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nephron Sc Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
10-11-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lots: 124081, 124082, Exp. 04/2023; 224031, Exp. 01/2024
Affected Packages Involved in this Recall
Recall Number: D-0177-2023
CGMP Deviations: potential for trace amounts of product carryover.
01-12-2023
02-01-2023
378 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Nephron Sc Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
10-11-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
Batch or Lot Expiration Information
Lot# Lot: 271043, Exp. 03/2023
