The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1350-2019·Announced 2019-06-19

Torrent Pharma Recalls Robafen AC Oral Solution Due to Bacterial Contamination

Torrent Pharma Inc. is recalling Robafen AC Oral Solution 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 severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Torrent Pharma Inc. is recalling 131,328 bottles of Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL. The product is distributed in one-pint (473 mL) bottles under NDC 0904-6479-16 by Major Pharmaceuticals Inc. The recall is due to current Good Manufacturing Practice (cGMP) deviations that resulted in potential product contamination with Burkholderia cepacia and Ralstonia pickettii.

The affected lots include 17M003, 18A009, 18A010, 18B024, 18F021, 18G009, 18G020, 18K005, and 18K011. The product was distributed to nine 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 and expiration dates listed above. If the product is found, it should be removed from use and returned to the distributor or the recalling firm.

The recalled product

Product
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
131,328

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 (15)

  • Lot #s: 17M003
  • Exp. 12/2019
  • 18A009
  • 18A010
  • Exp. 01/2020
  • 18B024
  • Exp. 02/2020
  • 18F021
  • Exp. 06/2020
  • 18G009
  • 18G020
  • Exp. 07/2020
  • 18K005
  • 18K011
  • Exp. 10/2020.

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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