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.
Product description
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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0101-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 3, 2020
- FDA report date
- Nov 25, 2020
- Quantity
- 2,100,646 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0101-2021, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86685
- Address
- 2 Esterbrook Ln
- Code information
- 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.
- Postal code
- 08003-4002
- Report date
- Nov 25, 2020
- Product type
- Drugs
- Recall number
- D-0101-2021
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 2,100,646 Vials
- Termination date
- Nov 17, 2022
- Reason for recall
- Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Nov 3, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2020