# FDA recall D-1378-2019

> **Torrent Pharma Inc** · Class II · drug recall initiated 2019-05-21.

## Product

Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.

## Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

## Distribution

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-1378-2019
- **Recalling firm:** Torrent Pharma Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-06-19
- **Termination date:** 2020-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Levittown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2019

## Citation

> AI Analytics. FDA recall D-1378-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1378-2019. Source: US FDA. Licensed CC0.

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