The Recall Desk
HighFDA (Drugs)·D-1352-2019·Announced 2019-06-19

Torrent Pharma Recalls Banophen Oral Solution Due to Bacterial Contamination Risk

Torrent Pharma Inc is recalling Banophen Oral Solution due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (bacterial contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Torrent Pharma Inc is recalling Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, containing diphenhydramine hydrochloride. The recall involves 655,104 bottles in 4 Fl. oz. and One Pint sizes. The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

The recall was initiated due to cGMP deviations that created a potential for product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The source text does not report any specific illnesses or injuries associated with the use of this product.

Consumers should stop using the recalled product and check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. The affected lots include various batches with expiration dates ranging from 05/2019 to 10/2020.

The recalled product

Product
Banophen Oral Solution, Sugar Free, Alcohol Free, Cherry Flavor, (Diphenhydramine HCl, USP) Each teaspoonful contains diphenhydramine hydrochloride, USP 12.5 mg, a) 4 Fl. oz. (118 mL) bottle, NDC: 0904-1228-00, b) One Pint (473 mL) bottle, NDC: 0904-5174-16, Distributed by Major
Manufacturer
Torrent Pharma Inc
Category
Drug — Oral Solution
Hazard
Affected units
655,104

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)17E018
  • 17E020
  • 17E026
  • Exp. 05/2019
  • 17H008
  • 17H018
  • 17H028
  • Exp. 08/2019
  • 17J002
  • 17J025
  • 17J028
  • Exp. 09/2019
  • 17L035
  • Exp. 11/2019
  • 17M024
  • Exp. 12/2019
  • 18A017
  • Exp. 01/2020
  • 18B016
  • Exp. 02/2020

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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