The Recall Desk
SevereFDA (Drugs)·D-1369-2019·Announced 2019-06-19

Torrent Pharma Recalls Extra Action Cough Syrup Due to Bacterial Contamination

Torrent Pharma Inc is recalling Extra Action Cough 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the classification of Class II for a drug product with bacterial contamination aligns with the Severe criteria in the absence of Class I indicators.

Plain-English summary

Torrent Pharma Inc is recalling 176,580 bottles of Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL. The recall involves 4 FL. oz. (118 mL) bottles (NDC: 0536-0970-97) and One Pint (473 mL) bottles (NDC: 0536-0970-85), distributed by Rugby Laboratories in Livonia, MI.

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 include 17E034, 17L023, 17M027, 17M027A, 18A024, 18B029, 18C018, 18C021, and 18E008, with expiration dates ranging from 05/2019 to 05/2020.

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 and expiration dates listed above and stop using the product if it matches the recalled items.

The recalled product

Product
Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Cough Syrup
Hazard
Affected units
176,580

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 (16)

  • Lot #s: 17E034
  • Exp. 05/2019
  • 17L023
  • Exp. 11/2019
  • 17M027
  • 17M027A
  • Exp. 12/2019
  • 18A024
  • Exp. 01/2020
  • 18B029
  • Exp. 02/2020
  • 18C018
  • 18C021
  • Exp. 03/2020
  • 18E008
  • Exp. 05/2020.

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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