The Recall Desk
SevereFDA (Drugs)·D-1367-2019·Announced 2019-06-19

Kid Kare Children's Cough/Cold Liquid Recalled for Bacterial Contamination

Torrent Pharma is recalling Kid Kare Children's Cough/Cold Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

What this means for you

Illness, injury, or structural failure has been reported. 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 and involves potential contamination with specific bacterial pathogens (Burkholderia cepacia and Ralstonia pickettii), which aligns with the rubric criteria for Severe severity involving significant health risks or Class II classifications with potential for adverse health consequences.

Plain-English summary

Torrent Pharma Inc is recalling 66,060 bottles of Kid Kare Children's Cough/Cold Liquid, a cherry-flavored, alcohol-free medication containing chlorpheniramine maleate, dextromethorphan HBr, and pseudoephedrine HCl. 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 is distributed in 4 Fl. oz. bottles under NDC 0536-2310-97. The recall covers specific lots with expiration dates ranging from May 2019 to September 2020, including lot numbers 17E009, 17L004, 17L004A, 17L020, 17M029, 18C010, 18C025, and 18J020. The product was distributed to nine distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the manufacturer for further instructions. This recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongestant, Cherry Flavored, Alcohol Free, (Chlorpheniramine Maleate, USP 2 mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in each 2 tsp (10mL)), 4 Fl. oz. bottle, NDC: 0536-2310
Manufacturer
Torrent Pharma Inc
Category
Drug — OTC Cough/Cold
Hazard
Affected units
66,060

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 (13)

  • Lot #s: 17E009
  • Exp. 05/2019
  • 17L004
  • 17L004A
  • 17L020
  • Exp. 11/2019
  • 17M029
  • Exp. 12/2019
  • 18C010
  • 18C025
  • Exp. 03/2020
  • 18J020
  • Exp. 09/2020.

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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