The Recall Desk
SevereFDA (Drugs)·D-1378-2019·Announced 2019-06-19

Torrent Pharma Recalls Hemorrhoidal Suppositories Due to Bacterial Contamination

Torrent Pharma is recalling 82,872 bottles of Hemorrhoidal 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, and the presence of specific bacterial contaminants (Burkholderia cepacia and Ralstonia pickettii) in a rectal product presents a significant risk of infection, meeting the criteria for a Severe rating.

Plain-English summary

Torrent Pharma Inc is recalling 82,872 bottles of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12. The product is distributed by Rugby Laboratories in Livonia, MI. The recall is due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected lots are 17L008 (Exp. 05/2019), 17M019, 17M037 (Exp. 06/2019), 18B012, and 18K023 (Exp. 04/2020). The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers should check their medication for the NDC 0536-1389-12 and the lot numbers listed above. If the product matches these details, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

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.
Manufacturer
Torrent Pharma Inc
Category
Drug — Topical/Rectal
Hazard
Affected units
82,872

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 (8)

  • Lot #s: 17L008
  • Exp. 05/2019
  • 17M019
  • 17M037
  • Exp. 06/2019
  • 18B012
  • 18K023
  • Exp. 04/2020.

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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