April 2019 FDA Recall Drug by Pacifico National, Inc. Dba Amex Pharmacy
D-1271-2019 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Pacifico National, Inc. Dba Amex Pharmacy on April 19, 2019 for the product Drug. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1271-2019
Defective Delivery System: difficult to express
04-19-2019
05-08-2019
249 syringes
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Pacifico National, Inc. dba AmEx Pharmacy
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US
02-16-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: 190212AB BUD: 5/13/2019