The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1370-2019·Announced 2019-06-19

Torrent Pharma Recalls Diphenhydramine Oral Solution Due to Bacterial Contamination

Torrent Pharma Inc is recalling Diphenhist 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 FDA classified this recall as Class II, and the source text identifies potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which aligns with the rubric criteria for a Severe rating involving significant health risks.

Plain-English summary

Torrent Pharma Inc is recalling 438,624 bottles of Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL. The product is available in 4 FL. oz. (118 mL) bottles (NDC: 0536-0770-97) and One Pint (473 mL) bottles (NDC: 0536-0770-85). The recall is 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 product was distributed to 9 distributors, direct accounts, and relabelers, who may have further distributed the product throughout the United States. Specific lot numbers and expiration dates are listed in the recall documentation. The FDA has classified this recall as Class II.

Consumers should stop using the recalled product and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
438,624

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) 17H025
  • Exp. 08/2019
  • 17M022
  • Exp. 12/2019
  • 18E011
  • Exp. 05/2020
  • 18G018
  • Exp. 07/2020
  • 18J014
  • Exp. 09/2020. b) 17E010
  • 17E030
  • Exp. 05/2019
  • 17F013
  • Exp. 06/2019
  • 17F010
  • Exp. 07/2019
  • 17J014
  • Exp. 09/2019
  • 17L005
  • Exp. 11/2019

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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