Leiter's Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns
Leiter's Pharmacy is recalling 265 vials of compounded Bevacizumab (Avastin) because a testing lab reported failed sterility results as passing, making the product's sterility unassured.
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 recall is classified as FDA Class II and involves a sterility failure in an injectable drug, which poses a risk of serious infection or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Leiter's Compounding Pharmacy is recalling 265 vials of Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe. The product was compounded by Leiter's Pharmacy in San Jose, California, and distributed nationwide. The specific lot numbers involved are 08052013@1 and 08052013@4, with an expiration date of 11/03/2013.
The recall was initiated due to a lack of assurance of sterility. An investigation revealed that a contract testing laboratory reported out-of-specification (OOS) or failed sterility results to customers as passing. Consequently, the sterility of the recalled products cannot be assured.
Patients who have received this medication should contact their healthcare provider for guidance. 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.
The recalled product
- Product
- Bevacizumab (Avastin) 2.5mg/0.1mL PF Inj., 0.1 mL syringe, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126
- Manufacturer
- Leiter's Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 265
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 (3)
- Lot #: 08052013@1
- 08052013@4
- Exp 11/03/2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Leiter's Pharmacy 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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