August 2019 FDA Recall Relpax by Pfizer Inc.
D-1845-2019 - Microbial Contamination of Non-Sterile Products
This Class II drug recall was voluntarily initiated by Pfizer Inc. on August 14, 2019 for the product Relpax. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1845-2019
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
08-14-2019
09-04-2019
a) 20,117 cartons; b) 2,502 cartons
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.
Pfizer Inc.
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.
Nationwide in the USA and Puerto Rico.
06-20-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.
Batch or Lot Expiration Information
Lot# : a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
