Recalls / Class II
Class IID-0101-2021
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. West-ward Eatontown, NJ 07724 USA, a) Vial NDC 0641-0497-17, b) Carton of 25 vials NDC 0641-0497-25.
- 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
- 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.
Why it was recalled
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, N/A, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 2,100,646 Vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-11-03
- FDA classified
- 2020-11-20
- Posted by FDA
- 2020-11-25
- Terminated
- 2022-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0101-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.