The Recall Desk
SevereFDA (Drugs)·D-1385-2019·Announced 2019-06-19

Torrent Pharma Recalls Bisacodyl Suppositories Due to Potential Bacterial Contamination

Torrent Pharma Inc is recalling specific lots of Bisacodyl Suppositories due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential contamination by high-risk pathogens or significant injury/property-damage reports are categorized as Severe (Score 4).

Plain-English summary

Torrent Pharma Inc is recalling specific lots of Bisacodyl Suppositories, Brite Stock, Reese. The recall is due to potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii), which resulted from Current Good Manufacturing Practice (cGMP) deviations.

The affected lots are 17J003 (Exp. 09/2019), 18A026 (Exp. 01/2020), and 18E031 (Exp. 05/2020). The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the source or disposed of according to local regulations. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Bisacodyl Suppositories, Brite Stock, Reese.
Manufacturer
Torrent Pharma Inc
Category
Drug — Suppositories
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot #s: 17J003
  • Exp. 09/2019
  • 18A026
  • Exp. 01/2020
  • 18E031
  • Exp. 05/2020.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 41 recalled by Torrent Pharma Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

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