The Recall Desk
SevereFDA (Drugs)·D-1357-2019·Announced 2019-06-19

Biscolax Laxative Suppositories Recalled for Potential Bacterial Contamination

Torrent Pharma is recalling Biscolax Laxative 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 FDA classified this as a Class II recall involving potential contamination with specific bacterial pathogens, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for adverse health consequences).

Plain-English summary

Torrent Pharma Inc is voluntarily recalling specific lots of Biscolax Laxative (Bisacodyl, USP 10 mg) suppositories. The recall involves 391,404 cartons, including 12-suppository and 100-suppository packages distributed by Major Pharmaceuticals Inc. The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

The recall is being conducted 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 FDA has classified this recall as Class II, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Consumers who have purchased the affected lots should stop using the product 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
Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Laxative
Hazard
Affected units
391,404

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) 17E004
  • 17E033
  • Exp. 05/2019
  • 17F019
  • Exp. 06/2019
  • 17G017
  • Exp. 07/2019
  • 17K009
  • 17K030
  • Exp. 10/2019
  • 17M006
  • 17M028
  • Exp. 12/2019
  • 18A029
  • Exp. 01/2020
  • 18C037
  • Exp. 03/2020
  • 18E002
  • Exp. 05/2020
  • 18F003

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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