FDA-Drug2019-09-04Class II
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.
Pfizer Inc.
Hazard
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Sold states
Nationwide in the USA and Puerto Rico.
Affected count
a) 20,117 cartons; b) 2,502 cartons
Manufactured in
235 E 42nd St, N/A, New York, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1845-2019Don't want to check this manually?
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