Recall 2019-140: Pfizer - Relpax - NYC - Consumer


URGENT!!!            DRUG RECALL!!!            URGENT!!!

Description

Lot #

Exp Date

NDC

UPC

RELPAX TAB 40MG BLIS-PAK 6

AR5407

2/28/2022

00049234045

30049234045

RELPAX TAB 40MG BLIS-PAK 12

CD4565

2/28/2022

00049234005

30049234005


Pfizer is voluntarily recalling the above items/lots due to these products may not meet Pfizer's in-house microbiological specification.  This recall is to the Consumer level.  Affected product started shipping June 2019.

Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life- threatening infections.

In addition, there is risk of temporary gastrointestinal distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis and chronic granulomatous disease) there may be the potential for serious adverse events including life- threatening infections. To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.

Consumers: Patients who are taking this product should consult with their health care provider or pharmacy to determine if they have the affected product lots.

Patients with the affected lots should return the product to their pharmacy or contact Stericycle at 877-225-9750 for instructions on how to return their product and obtain reimbursement for their cost.

This recall is being conducted with the knowledge of the FDA.

Contact:

Pfizer: Stericycle Pfizer 877-225-9750