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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: C0001088/P0001317, Exp. Date 08/2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Exela Pharma Sciences LLC
- Reason for Recall:
- Lack of Assurance of Sterility
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Lot #: C0001088/P0001317, Exp. Date 08/2023
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0369-2022
Related Recalls
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Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Presence of Particulate Matter: Silicone