The Recall Desk
SevereFDA (Drugs)·D-1379-2019·Announced 2019-06-19

Torrent Pharma Recalls Anu-Med Hemorrhoidal Suppositories Due to Bacterial Contamination

Torrent Pharma is recalling Anu-Med 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, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from bacterial contamination in a medical product.

Plain-English summary

Torrent Pharma Inc is recalling Anu-Med brand Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%) because of potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The recall involves 177,408 bottles of the product, which is distributed in cartons of 12 suppositories.

The affected product is identified by NDC 0904-7688-22 and is distributed by Major Pharmaceuticals in Livonia, MI. The recall covers specific lots with expiration dates ranging from May 2019 to June 2020. The product was distributed to nine distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers should stop using the recalled suppositories and contact their healthcare provider or the recalling firm for instructions on how to return the product or obtain a replacement.

The recalled product

Product
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Topical / Rectal
Hazard
Affected units
177,408

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 (17)

  • Lot #s: 17L008
  • Exp. 05/2019
  • 17M011
  • 17M037
  • Exp. 06/2019
  • 18A015
  • Exp. 07/2019
  • 18B012
  • 18B023
  • Exp. 08/2019
  • 18K023
  • 18K029
  • Exp. 04/2020
  • 18L014
  • Exp. 05/2020
  • 19A001
  • Exp. 06/2020.

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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