Recalls / Class II
Class IID-1845-2019
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.
- Brand name
- Relpax
- Generic name
- Eletriptan Hydrobromide
- Active ingredient
- Eletriptan Hydrobromide
- Route
- Oral
- NDCs
- 0049-2330, 0049-2340
- FDA application
- NDA021016
- Affected lot / code info
- Lot #: a) AR5407, Exp 2022 FEB; b) CD4565, Exp 2022 FEB
Why it was recalled
Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- ROERIG
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- a) 20,117 cartons; b) 2,502 cartons
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-08-14
- FDA classified
- 2019-08-28
- Posted by FDA
- 2019-09-04
- Terminated
- 2023-06-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1845-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.