Why it was recalled
Lack of Assurance of Sterility
Product description
8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
Lot numbers, UPCs & expiration codes
Lot #: C0001088/P0001317, Exp. Date 08/2023
Where it was sold
Nationwide within the United States
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-0369-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2022
- FDA report date
- Jan 19, 2022
- Quantity
- 18,960 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Exela Pharma Sciences LLC
Original FDA data
Every field from FDA enforcement report D-0369-2022, exactly as published.
Show all FDA fields
- City
- Lenoir
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 89402
- Address
- 1245 Blowing Rock Blvd
- Code information
- Lot #: C0001088/P0001317, Exp. Date 08/2023
- Postal code
- 28645-3618
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0369-2022
- Classification
- Class II
- Recalling firm
- Exela Pharma Sciences LLC
- Product quantity
- 18,960 vials
- Termination date
- Dec 2, 2022
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC., Lenoir, NC 28645, NDC 51754-5001-1
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2022