AmEx Pharmacy Recalls Bevacizumab Syringes Due to Defective Delivery System
AmEx Pharmacy is recalling 249 syringes of Bevacizumab intravitreal injection because the delivery system is difficult to express.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the defect is a mechanical issue (difficult to express) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Pacifico National, Inc. dba AmEx Pharmacy is recalling 249 syringes of Bevacizumab 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. The product was repackaged by AmEx Pharmacy in Melbourne, Florida, and distributed nationwide in the US.
The recall was initiated because the delivery system is defective and difficult to express. The affected product is identified by Lot 190212AB with a beyond-use date of May 13, 2019.
Consumers and healthcare providers should stop using the affected syringes and contact AmEx Pharmacy for further instructions or a return.
The recalled product
- Product
- BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019
- Manufacturer
- Pacifico National, Inc. dba AmEx Pharmacy
- Affected units
- 249
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)
- Lot: 190212AB BUD: 5/13/2019
Distribution
Distributed nationwide across the United States.
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