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.
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 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.
- Manufacturer
- Ranier's Compounding Laboratory
- 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.
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