The Recall Desk
SevereFDA (Drugs)·D-1368-2019·Announced 2019-06-19

Torrent Pharma Recalls Cough Syrup Due to Potential Bacterial Contamination

Torrent Pharma Inc is recalling 249,744 bottles of Guaifenesin Syrup 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 contamination with specific bacterial pathogens.

Plain-English summary

Torrent Pharma Inc is recalling 249,744 bottles of Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85. The product is distributed by Rugby Laboratories in Livonia, MI.

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 17F022, 17G027, 17H021, 17H021A, 17J008, 17L001, 17M015, 18A018, 18B003, 18B008, 18C012, 18D005, 18F008, 18F043, 18G025, 18H004, 18H007, and 18H016, with expiration dates ranging from 06/2019 to 08/2020.

The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States. Consumers should check their inventory for the specific lot numbers listed above and discontinue use if found.

The recalled product

Product
Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle, NDC: 0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Liquid Cough Syrup
Hazard
Affected units
249,744

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: 17F022
  • Exp. 06/2019
  • 17G027
  • Exp. 07/2019
  • 17H021
  • 17H021A
  • Exp. 08/2019
  • 17J008
  • Exp. 09/2019
  • 17L001
  • Exp. 11/2019
  • 17M015
  • Exp. 12/2019
  • 18A018
  • Exp. 01/2020
  • 18B003
  • 18B008
  • Exp. 02/2020
  • 18C012
  • Exp. 03/2020

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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