AmEx Pharmacy Recalls Bevacizumab Syringes Due to Sterility Concerns
Pacifico National, Inc. dba AmEx Pharmacy is recalling Bevacizumab intravitreal injections because of a lack of assurance of sterility. The recall covers all lots remaining within expiry in the Continental U.S. and Puerto Rico.
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. According to the rubric, FDA Class II recalls with potential for serious injury (such as sterility failures in injectable drugs) are classified as Severe.
Plain-English summary
Pacifico National, Inc. dba AmEx Pharmacy is recalling Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection. The product is a single-use, prescription-only medication repackaged by AmEx Pharmacy in Melbourne, Florida. The recall is being conducted due to a lack of assurance of sterility.
The recall includes all lots remaining within their expiry dates. The affected products were distributed to the Continental U.S. and Puerto Rico.
Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject 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
- 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 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
Same manufacturer · Pacifico National, Inc. dba AmEx Pharmacy
See all →- SevereFDA Recalls Bevacizumab Intravitreal Injection Due to Sterility Concerns
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