Sodium Bicarbonate Injection recalled for glass particulate contamination
Pfizer is recalling 34,000 cartons of 4.2% Sodium Bicarbonate Injection nationwide due to glass particles in the solution. Patients should immediately stop use and contact their supplier.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. Glass contamination in an intravenous injection presents a significant risk to patient safety. Although no illnesses or deaths have been reported, the hazard and agency classification establish this as Severe rather than Critical.
Plain-English summary
Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL supplied in glass ABBOJECT unit-of-use syringes. The recall affects 34,000 cartons distributed nationwide in the United States and Puerto Rico, with NDC codes 0409-5534-24 (carton) and 0409-5534-14 (case).
The recall was initiated due to the presence of glass particulate matter identified in the product. Glass contamination in an intravenous injection presents a potential safety risk to patients.
The affected lot is GX1542 with an expiration date of January 1, 2025. Healthcare providers and patients should verify their lot numbers against this information to determine if they have received affected product.
If you have received this product, do not use it. Contact your supplier immediately to report the recall and arrange for the return or replacement of affected units. Healthcare providers should review patient records to determine if this recalled product was administered to any patients.
The recalled product
- Product
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
- Manufacturer
- Pfizer Inc.
- Category
- Drug
- Hazard
- Affected units
- 34,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot GX1542
- Exp. 01/01/2025
Distribution
Part of a larger recall action
This product is one of 3 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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