Relpax
FDA Recall NDC 0049-2340
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Relpax (NDC 0049-2340). A significant event, classified as Class II, was initiated on Aug 14, 2019 by Roerig. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
August 2019 Class II Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class II Terminated
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Aug 14, 2019
Sep 04, 2019
a) 20,117 cartons; b) 2,502 cartons
Recall Profile & Regulatory Data
Event ID
83533
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Jun 20, 2023
Product Description
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
Affected Packages Involved in this Recall
0049-2330-79Product
0049-2330-45Product
0049-2340-79Product
0049-2340-45Product
0049-2340-05Product
Class III Terminated
Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Apr 29, 2019
May 22, 2019
100277 tablets
Recall Profile & Regulatory Data
Event ID
82715
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 26, 2021
Product Description
Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per blister pack, NDC 0049-2340-05; b) 6 tablets 1 card x six 40 mg tablets per blister pack, NDC 0049-2340-45, Rx Only, Made in Ireland, Distributed by Roerig, Division of Pfizer Inc, NY NY 10017.
Batch or Lot Expiration Information
Lot# s: a) W38322, Exp 10/2020, W98482, Exp 03/2021; b) W64062, Exp 01/2021, X27517, Exp 03/2021, AJ3674, Exp 11/2021.
Affected Packages Involved in this Recall
0049-2330-79Product
0049-2330-45Product
0049-2340-79Product
0049-2340-45Product
0049-2340-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
