The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1665-2019·Announced 2019-08-14

RXQ Compounding Recalls Hydromorphone Syringes Due to Sterility Concerns

RXQ Compounding LLC is recalling hydromorphone syringes because the company cannot ensure the product is 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a sterile injectable medication where sterility cannot be assured, posing a risk of harm (infection) even though no illnesses have been reported yet, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

RXQ Compounding LLC is recalling specific lots of Hydromorphone 0.2mg/mL in NaCl 0.9% Syringe (C-II). The recall involves 50 mL and 55 mL syringes with NDC numbers 70731-0114-89 and 70731-0114-95, respectively. The product was distributed nationwide in the United States.

The reason for the recall is a lack of assurance of sterility. The source text does not specify which lots are affected beyond stating "All lots within expiry," nor does it provide specific expiration dates or lot numbers.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89; b) 55 ML NDC 70731-0114-95] per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable 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.

See all 86 products in this recall →

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