The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1637-2019·Announced 2019-08-14

RXQ Compounding Recalls Avastin Syringes Due to Sterility Concerns

RXQ Compounding LLC is recalling Avastin 25mg/mL syringes because the company cannot ensure the product is sterile. The recall covers all lots within their expiration dates.

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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant health risks.

Plain-English summary

RXQ Compounding LLC is voluntarily recalling Avastin 25mg/mL syringes. The recall is being conducted because the company lacks assurance that the product is sterile. The affected products are identified by NDC numbers 70731-0197-91, 70731-0197-92, and 70731-0197-93, corresponding to 0.1 mL, 0.12 mL, and 0.15 mL vials, respectively.

The recall applies to all lots of these specific syringes that are within their expiration dates. The products were distributed 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.

Consumers and healthcare providers should stop using the recalled Avastin syringes and contact their healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.

The recalled product

Product
Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-0197-92; c) 0.15 mL NDC 70731-0197-93] per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701.
Manufacturer
RXQ Compounding LLC
Category
Drug — Injectable
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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