The Recall Desk
SevereFDA (Drugs)·D-1697-2019·Announced 2019-08-14

RXQ Compounding Recalls Procaine HCL Injectable Solution Due to Sterility Concerns

RXQ Compounding LLC is recalling Procaine HCL 20 mg/mL Injectable Solution because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

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 and involves a lack of assurance of sterility in an injectable solution, which poses a risk of serious adverse health consequences such as infection, meeting the criteria for a Severe rating.

Plain-English summary

RXQ Compounding LLC is recalling Procaine HCL (PFV) 20 mg/mL Injectable Solution, 30 mL per vial, due to a lack of assurance of sterility. The product is identified by NDC 70731-0900-30 and is manufactured by RXQ Compounding LLC, located at 340 West State Street, Unit 9, Athens, OH 45701.

The recall includes all lots within their expiration dates. The distribution pattern for the affected product is nationwide in the United States. 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.

Healthcare providers and patients should stop using the recalled product immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or to determine if they have been affected. No specific lot numbers or dates are provided in the source text, so all lots within expiry should be considered affected.

The recalled product

Product
PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0900-30

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 →