All PlansCoverageHigh impact
Voluntary nationwide recall: Exela Pharma (October)
UPMC Health Plan·Pharmacy, Critical Care, Emergency Medicine +1 more·Pharmacy
Effective date
Oct 1, 2023
We identified it
Aug 7, 2026
Summary
Exela Pharma is voluntarily recalling multiple lots of 8.4% Sodium Bicarbonate Injection, USP (NDC: 51754-5001-04) due to silicone particles contaminating the product. Silicone particles can cause local irritation, blood vessel blockage, stroke, and death if administered. Billing teams must identify and halt claims for affected lots, ensure providers stop using recalled inventory, and coordinate with pharmacy and clinical staff to prevent patient administration.
Action Required
IMMEDIATE (within 24 hours): Billing team must coordinate with clinical and pharmacy leadership to: (1) Identify all claims submitted in the past 30 days for NDC 51754-5001-04 (Exela 8.4% Sodium Bicarbonate Injection); (2) Flag and hold all pending claims for this NDC until lot numbers are verified against the recall list; (3) Alert providers and nursing staff to STOP using inventory immediately and verify lot numbers against the FDA recall notice; (4) For claims already paid, prepare communication to providers for potential reversal and credit memos if recalled lots were billed; (5) Document all affected patients who may have received the recalled product and ensure clinical notification for adverse event monitoring; (6) Update billing system to flag NDC 51754-5001-04 claims for manual review until recall is fully resolved. Failure to act may result in claims for administered contaminated product, patient harm liability, and regulatory violations.