# FDA recall D-1278-2019

> **Pfizer Inc.** · Class III · drug recall initiated 2019-04-29.

## Product

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.

## Reason for recall

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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1278-2019
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-29
- **Report date:** 2019-05-22
- **Termination date:** 2021-04-26

- **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-1278-2019

## Citation

> AI Analytics. FDA recall D-1278-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1278-2019. Source: US FDA. Licensed CC0.

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