RXQ Compounding Recalls Turbo Caine 2.5 Due to Sterility Concerns
RXQ Compounding LLC is recalling Turbo Caine 2.5 syringes because the FDA determined there is a lack of assurance of sterility.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a risk of harm (lack of sterility) where injury has not yet been reported is categorized as Severe (Score 4), as it exceeds the criteria for High (Score 3) which typically applies to theoretical risks or specific high-risk pathogens without reported illness, but Class II implies a higher potential for adverse health consequences than Class III.
Plain-English summary
RXQ Compounding LLC is voluntarily recalling Turbo Caine 2.5 (PHEN2.5/CYCLO1/TROP1/TETRA 0.5), 0.4 mL per syringe, under FDA recall number D-1712-2019. The product is a compounded medication containing phenylephrine, cyclopentolate, tropicamide, and tetracaine.
The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed nationwide in the United States. All lots within the expiration date are included in this recall. Patients who have received this medication should contact their healthcare provider for further instructions.
The recalled product
- Product
- TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC 70731-0193-81
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Compounded Medication
- Hazard
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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