Recalls / Class II
Class IID-0169-2021
Product
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0641-0497, 0641-6144
- FDA application
- ANDA201833
- Affected lot / code info
- Lot#: 048315 EXP 4/2021; 068320 EXP 6/2021; 128302 EXP 12/2021; 099349 EXP 9/2022.
Why it was recalled
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, N/A, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 1,324,072 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-12-07
- FDA classified
- 2020-12-16
- Posted by FDA
- 2020-12-23
- Terminated
- 2023-07-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0169-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.