The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1377-2019·Announced 2019-06-19

Torrent Pharma Recalls Laxative Suppositories Due to Potential Bacterial Contamination

Torrent Pharma Inc is recalling Laxative Suppositories (Bisacodyl USP, 10 mg) due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 drug product poses a significant health risk, meeting the criteria for a Severe rating.

Plain-English summary

Torrent Pharma Inc is recalling Laxative Suppositories (Bisacodyl USP, 10 mg) in 12-suppository and 100-suppository cartons. The recall is due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected products are distributed by Rugby Laboratories in Livonia, MI. The recall covers 120,204 cartons. The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Laxative
Hazard
Affected units
120,204

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 (20)

  • Lot #s: a) 17K009
  • Exp. 10/2019
  • 17M028
  • Exp. 12/2019
  • 18F003
  • Exp. 06/2020
  • 18J022
  • Exp. 09/2020
  • 18L012
  • Exp. 11/2020
  • 19A008
  • Exp. 01/2021. b) 17G004
  • 17G028
  • Exp. 07/2019
  • 18A034
  • Exp. 01/2020
  • 18C016
  • Exp. 03/2020
  • 18E005
  • 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 →

Related recalls

Same manufacturer · Torrent Pharma Inc

See all →

Same hazard · bacterial contamination

See all →

Similar recalls