RXQ Compounding Recalls Riboflavin Ophthalmic Solution Due to Sterility Concerns
RXQ Compounding LLC is recalling Riboflavin 0.1% Ophthalmic Solution syringes because the product lacks 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an ophthalmic product poses a significant risk of serious harm, aligning with the Severe classification for Class II recalls with potential for significant injury.
Plain-English summary
RXQ Compounding LLC is recalling Riboflavin 0.1% Ophthalmic Solution syringes (2 mL per syringe, NDC: 70731-0923-02). The recall was initiated because the product lacks assurance of sterility.
The affected product was distributed nationwide in the United States. The recall includes all lots within their expiration dates. No specific lot numbers or dates are provided in the source text.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0923-02
- Manufacturer
- RXQ Compounding LLC
- Category
- Drug — Ophthalmic Solution
- 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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