# FDA recall D-1845-2019

> **Pfizer Inc.** · Class II · drug recall initiated 2019-08-14.

## 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.

## Reason for recall

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-1845-2019
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-08-14
- **Report date:** 2019-09-04
- **Termination date:** 2023-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1845-2019

## Citation

> AI Analytics. FDA recall D-1845-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-1845-2019. Source: US FDA. Licensed CC0.

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