RXQ Compounding Recalls Midazolam Injection Due to Sterility Concerns
RXQ Compounding LLC is recalling Midazolam 1mg/mL injection syringes 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 recall is classified as FDA Class II. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if contaminated, fitting the criteria for a Severe rating.
Plain-English summary
RXQ Compounding LLC is recalling Midazolam 1mg/mL in NaCl 0.9% Injection Solution Syringes (C-IV), 10 mL per syringe. The recall is being conducted because the product lacks assurance of sterility. The affected product is identified by NDC 70731-0135-86.
The recall includes all lots within their expiration dates. The product was distributed nationwide in the United States. The source text does not specify the number of units recalled or the specific expiration dates involved.
Healthcare providers and patients should stop using the recalled product. The source text does not provide specific instructions for disposal or return, but standard medical protocol for recalled sterile injectables typically involves quarantining the product and contacting the manufacturer or regulatory authorities for guidance.
The recalled product
- Product
- MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0135-86
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Injectable Medication
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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