The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1355-2019·Announced 2019-06-19

Torrent Pharma Recalls Robafen DM Cough Syrup Due to Bacterial Contamination

Torrent Pharma Inc is recalling Robafen DM Cough Sugar-Free Clear Cough Expectorant 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 significant injury from bacterial contamination in a pharmaceutical product.

Plain-English summary

Torrent Pharma Inc is recalling 262,008 bottles of Robafen DM Cough Sugar-Free Clear Cough Expectorant (NDC: 0904-6306-20). The product is a 4 Fl. oz. (118 mL) liquid cough syrup containing Dextromethorphan HBr and Guaifenesin. 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 product was distributed to 9 distributors, direct accounts, and relabelers, who may have further distributed the product throughout the United States. The recall covers specific lot numbers with expiration dates ranging from May 2019 to April 2020, including lots 17E016, 17E017, 17F023, 17F023A, 17L018, 17L029, 17L030, 17L031, 17M035, 18B002, 18B014, 18B035, 18C002, 18C019, and 18D013.

Consumers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact the manufacturer or their healthcare provider for instructions on disposal or replacement.

The recalled product

Product
Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle, NDC: 0904-6306-20, Distributed by Major Pharmaceuticals, Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Cough Syrup
Hazard
Affected units
262,008

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: 17E016
  • 17E017
  • Exp. 05/2019
  • 17F023
  • 17F023A
  • Exp. 06/2019
  • 17L018
  • 17L029
  • 17L030
  • 17L031
  • Exp. 11/2019
  • 17M035
  • Exp. 12/2019
  • 18B002
  • 18B014
  • 18B035
  • Exp. 02/2020
  • 18C002
  • 18C019
  • 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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