FDAClass IINovember 25, 2020

Sodium Chloride Injection recall

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.…

Why was Sodium Chloride Injection recalled?

Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.

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?

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.

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.…
Recalling firm
Hikma Pharmaceuticals USA Inc.
Quantity
2,100,646 Vials
Distribution
Nationwide in the U.S.
Recall date
November 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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