Recalls / Class I
Class ID-0116-2024
Product
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
- Brand name
- Sodium Bicarbonate
- Generic name
- Sodium Bicarbonate
- Active ingredient
- Sodium Bicarbonate
- Route
- Intravenous
- NDCs
- 51754-5001, 51754-5011, 51754-5002, 51754-5012
- FDA application
- ANDA211091
- Affected lot / code info
- a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024
Why it was recalled
Presence of Particulate Matter: Silicone
Recalling firm
- Firm
- Exela Pharma Sciences LLC
- Manufacturer
- Exela Pharma Sciences, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1245 Blowing Rock Blvd, N/A, Lenoir, North Carolina 28645-3618
Distribution
- Quantity
- 355,220 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-18
- FDA classified
- 2023-11-22
- Posted by FDA
- 2023-11-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0116-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.