The Recall Desk
SevereFDA (Drugs)·D-1372-2019·Announced 2019-06-19

Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination

Torrent Pharma Inc. is recalling 96,060 bottles of Lactulose Solution 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 severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling 96,060 bottles of Lactulose Solution, USP 10 g/15 mL, for oral administration. The affected products are available in 16 FL. oz. and 32 FL. oz. sizes and were manufactured by Bio-Pharm Inc. for Torrent Pharma Inc.

The recall was initiated 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 lots include specific expiration dates ranging from October 2020 to January 2021.

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 the specific NDCs and lot numbers listed in the recall notice and stop using the product if it matches the affected lots.

The recalled product

Product
Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
96,060

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 (12)

  • Lot #s: a) 18K025
  • 18K027
  • Exp. 10/2020
  • 18L001
  • 18L006
  • 18L007
  • Exp. 11/2020
  • 18M013
  • Exp. 12/2020
  • 19A006
  • Exp. 01/2021. b) 18K027
  • Exp. 01/2021.

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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