The Recall Desk
SevereFDA (Drugs)·D-1082-2018·Announced 2018-08-22

Ranier's Compounding Laboratory Recalls Avastin Prefilled Syringes Due to Sterility Concerns

Ranier's Compounding Laboratory is recalling 213 Avastin prefilled syringes because practices at the firm may call into question the sterility of the products.

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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical devices/drugs.

Plain-English summary

Ranier's Compounding Laboratory is recalling 213 prefilled syringes of Avastin 1.25 mg/0.05 mL. The product is prescription-only and was distributed within the state of Pennsylvania. The recall covers all lots within expiry.

The recall was initiated due to a lack of assurance of sterility. According to the FDA, practices at the firm may call into question the sterility of products intended to be sterile.

Consumers who have this product should contact their healthcare provider for guidance on what to do with the recalled syringes.

The recalled product

Product
Avastin 1.25 mg/0.05 mL prefilled syringe, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Affected units
213

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 in 1 state:

Part of a larger recall action

This product is one of 15 recalled by Ranier's Compounding Laboratory 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 15 products in this recall →