Class II
Terminated
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
This recall has been terminated (originally issued December 23, 2020).
- Company
- Hikma Pharmaceuticals Usa Inc.
- Recall Initiated
- December 7, 2020
- Posted
- December 23, 2020
- Recall Number
- D-0169-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,324,072 vials
- Firm Location
- Cherry Hill, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
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