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healthClass IIRecalled on Sep 17, 2025

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only

🔢 N/A

Sold At: Exela Pharma Sciences LLC(Nationwide in the USA)

Recall #: FDA-DRUG-D-0620-2025

Source: FDA-ENFORCEMENT

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only

Product Identification

Lot/Batch Codes:
Lot # 10004077, Exp. 02/28/2026

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Summary

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

What to do next

  • 1Stop using this product - may cause temporary or medically reversible health problems
  • 2Check with retailer or manufacturer for recall status and remedy options
  • 3Contact Exela Pharma Sciences LLC for return or refund information
  • 4Visit the official FDA recall page for complete details

Summaries only; always follow the official notice.