Sodium Bicarbonate Injection recalled due to glass contamination
Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection (24,900 vials) nationwide due to the presence of glass particulate matter. This Class I recall affects an injectable medication used in healthcare settings.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls warrant a minimum score of 4 (Severe). The source text does not report any illnesses or injuries, so the score remains at 4 rather than escalating to 5 (Critical).
Plain-English summary
Pfizer Inc. is recalling 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL due to the presence of glass particulate matter identified in the product. The affected medication is supplied as glass ABBOJECT Unit of Use Syringes. Lot GJ5007 with an expiration date of August 1, 2024 is affected.
The recalled product (24,900 vials total) was distributed nationwide in the United States and Puerto Rico. Distribution was limited to healthcare facilities and providers; government accounts and foreign consignees were not supplied.
This is a Class I recall, the FDA's most serious recall classification. Presence of glass particulate matter in injectable medication presents a contamination hazard.
The recalled product
- Product
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
- Manufacturer
- Pfizer Inc.
- Category
- Drug
- Hazard
- glass-contamination
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#: GJ5007
- Exp. 8/1/2024
Distribution
Distributed nationwide across the United States.
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