RXQ Compounding Recalls Phenylephrine Syringes Due to Sterility Concerns
RXQ Compounding LLC is recalling Phenylephrine HCL 100 mcg/mL syringes because the agency could not ensure the product was sterile.
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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as sterility issues in injectable products.
Plain-English summary
RXQ Compounding LLC is recalling Phenylephrine HCL 100 mcg/mL in NaCl 0.9% Syringe, 10 mL per syringe (NDC: 70731-0136-10). The recall was initiated due to a lack of assurance of sterility for the product.
The affected product was distributed nationwide in the United States. The recall covers all lots within their expiration dates.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0136-10
- Manufacturer
- RXQ Compounding LLC
- 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.
See all 86 products in this recall →Related recalls
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