Multi-event August 2019 FDA Recall Drug by Pacifico National, Inc. Dba Amex Pharmacy
This Multi-event Class II drug recall was voluntarily initiated by Pacifico National, Inc. Dba Amex Pharmacy on August 30, 2019 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility.. The product was distributed in Continental U.S. and Puerto Rico and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1849-2019
Lack of assurance of sterility.
08-30-2019
09-18-2019
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Continental U.S. and Puerto Rico
10-08-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
Recall Number: D-1850-2019
Lack of assurance of sterility.
08-30-2019
09-18-2019
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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Continental U.S. and Puerto Rico
10-08-2020
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, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Batch or Lot Expiration Information
Lot# All lots remaining within expiry.
