FDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns
AmEx Pharmacy is recalling Bevacizumab intravitreal injections because the product lacks assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.
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. According to the rubric, FDA Class II recalls with potential for significant injury (such as sterility failure in an injectable drug) are classified as Severe (Score 4).
Plain-English summary
Pacifico National, Inc. dba AmEx Pharmacy is recalling Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection. The product is a single-use, prescription-only medication repackaged by AmEx Pharmacy in Melbourne, Florida.
The recall was initiated due to a lack of assurance of sterility. The source text does not specify the exact cause of the sterility concern or report any specific illnesses or injuries associated with the product.
The recall affects all lots remaining within their expiry dates. The product was distributed to the Continental U.S. and Puerto Rico. Patients who have received this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
- Manufacturer
- Pacifico National, Inc. dba AmEx Pharmacy
- Category
- Drug — Biologic / Injectable
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 remaining within expiry.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Pacifico National, Inc. dba AmEx 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.
See all 2 products in this recall →Related recalls
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