Sodium Bicarbonate Injection Recalled for Sterility Assurance Concerns
Natures Pharmacy & Compounding Center is recalling all lots of Sodium Bicarbonate 8.4% injection due to quality control issues affecting sterility assurance.
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: The source text identifies the agency classification as Class II and cites a 'potential risk to sterility assurance' for a sterile injectable product, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with serious potential consequences.
Plain-English summary
Natures Pharmacy & Compounding Center is recalling all lots of Sodium Bicarbonate 8.4% injection. The recall covers all lots within their expiry dates. The distribution is limited to North Carolina.
The recall was initiated due to concerns regarding quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Sodium Bicarbonate 8.4% inj.
- Manufacturer
- Natures Pharmacy & Compounding Center
- Category
- Drug — Injectable
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 (1)
- All lot numbers within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 48 recalled by Natures Pharmacy & Compounding Center 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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