The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1351-2019·Announced 2019-06-19

Torrent Pharma Recalls Robafen DM Syrup Due to Bacterial Contamination Risk

Torrent Pharma is recalling Robafen DM Syrup due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 contamination with specific bacterial pathogens.

Plain-English summary

Torrent Pharma Inc is recalling Robafen DM Syrup, a cough and cold medication containing dextromethorphan and guaifenesin. The recall is being conducted due to current Good Manufacturing Practice (cGMP) deviations that created a potential for product contamination with Burkholderia cepacia and Ralstonia pickettii.

The affected product is distributed by Major Pharmaceuticals Inc. and is available in 4 oz, 8 oz, and 16 oz bottles. Approximately 1,500,672 bottles were 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 in the recall notice. If you possess the affected product, you should stop using it and contact the manufacturer or your healthcare provider for instructions on disposal or replacement.

The recalled product

Product
Robafen DM Syrup (Dextromethorphan HBr, USP 20 mg/10 mL and Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c) 16 oz. bottle, NDC:0904-0053-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Cough and Cold
Hazard
Affected units
1,500,672

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: a) 17F001
  • Exp. 06/2019
  • 17G016
  • Exp. 07/2019
  • 17H017
  • Exp. 08/2019
  • 17L002
  • 17L024
  • Exp. 11/2019
  • 17M010
  • 17M013
  • Exp. 12/2019
  • 18B006
  • 18B031
  • Exp. 02/2020
  • 18C033
  • Exp. 03/2020
  • 18D015
  • 18D016
  • Exp. 04/2020

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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