The Recall Desk
SevereFDA (Drugs)·D-1373-2019·Announced 2019-06-19

Torrent Pharma Recalls Lactulose Solution Due to Potential Bacterial Contamination

Torrent Pharma Inc. is recalling specific lots 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. Per the rubric, FDA Class II recalls with potential contamination by high-risk pathogens or significant injury reports are rated as Severe (4).

Plain-English summary

Torrent Pharma Inc. is recalling 153.540 bottles of Lactulose Solution, USP 10 g/15 mL, 16 FL. oz. bottles. The product is a prescription medication for oral or rectal administration. The recall was initiated due to cGMP deviations that resulted in potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii).

The affected lots are 18E016, 18E029, 18F004, 18F005, 18F039, 18G010, 18G017, 18H019, 18M008, 19A005, and 19B010. 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 lot numbers listed above. If the product is found, it should be returned to the distributor or pharmacy of purchase. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
Manufacturer
Torrent Pharma Inc
Category
Drug — Prescription Medication
Hazard

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 (18)

  • Lot #s: 18E016
  • 18E029
  • Exp. 05/2020
  • 18F004
  • 18F005
  • 18F039
  • Exp. 06/2020
  • 18G010
  • 18G017
  • Exp. 07/2020
  • 18H019
  • Exp. 08/2020
  • 18M008
  • Exp. 12/2020
  • 19A005
  • Exp. 01/2021
  • 19B010
  • Exp. 02/2021.

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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