RXQ Compounding Recalls Thiamine HCL Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Thiamine HCL 100mg/mL Injection because the product lacks assurance of sterility. The recall covers all lots within expiry 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which carries a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
RXQ Compounding LLC is recalling Thiamine HCL 100mg/mL (MDV) Injection, 10 mL per Vial (NDC 70731-0950-10). The recall was initiated because the product lacks assurance of sterility. The affected product is distributed nationwide in the United States, and the recall includes all lots within their expiration dates.
This recall involves a prescription drug product. The specific hazard identified is the potential presence of microbial contamination due to the lack of sterility assurance. No specific lot numbers or dates are provided in the source text beyond the general instruction to include all lots within expiry.
Healthcare providers and patients who have received or used this product should contact their healthcare provider for guidance. The recalling firm is RXQ Compounding LLC, located at 340 West State Street, Unit 9, Athens, OH 45701.
The recalled product
- Product
- THIAMINE HCL 100MG/ML (MDV) INJECTION, 10 ML per Vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0950-10
- Manufacturer
- RXQ Compounding LLC
- 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 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.
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