RXQ Compounding Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Sodium Bicarbonate 8.4% Injection due to a lack of assurance of sterility. The product is distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
RXQ Compounding LLC is recalling Sodium Bicarbonate 8.4% (1 mEq/mL) Injection Solution (PFV), 50 mL per vial, NDC 70731-0957-50. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is distributed nationwide in the United States. The recall covers all lots within their expiration dates. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. No specific illness or injury reports are mentioned in the source text.
The recalled product
- Product
- SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0957-50
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Solution
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 lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 86 recalled by RXQ Compounding LLC 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.
See all 86 products in this recall →Related recalls
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