November 2020 FDA Recall Sodium Chloride by Hikma Pharmaceuticals Usa Inc.
D-0101-2021 - Failed pH Specifications

This Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on November 3, 2020 for the product Sodium Chloride. The FDA reported the reason for recall as failed ph specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0101-2021

Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Initiated
11-03-2020
Reported
11-25-2020
Quantity
2,100,646 Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86685
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hikma Pharmaceuticals USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-17-2022
Product Description About Product Description
Full technical description of the product.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile diluent, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.

Batch or Lot Expiration Information

Lot# a) Vial
Lot# s: 078338 Exp. 7/2021; Lot 088391, Exp. 08/2021; 098340, Exp. 09/2021; 108325 Exp. 10/2021; 010018 Exp. 1/2023; b) Carton
Lot# : 068322, Exp. 06/2021.

Affected Packages Involved in this Recall

0641-0497-17 Sodium Chloride
0641-0497-25 Sodium Chloride
0641-6144-01 Sodium Chloride
0641-6144-25 Sodium Chloride