The Recall Desk
SevereFDA (Drugs)·D-1348-2019·Announced 2019-06-19

Torrent Pharma Recalls Children's Mapap Acetaminophen Liquid Due to Contamination

Torrent Pharma is recalling Children's Mapap Acetaminophen 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, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant injury from bacterial contamination in a pediatric medication.

Plain-English summary

Torrent Pharma Inc is recalling Children's Mapap Acetaminophen Liquid, a fever reducer and pain reliever, due to potential product contamination with Burkholderia cepacia (B. cepacia) and Ralstonia pickettii (R. pickettii). The recall involves 2,646,228 bottles of the cherry-flavored liquid, which is alcohol-free and aspirin-free.

The affected products are distributed by Major Pharmaceuticals in Livonia, MI. The recall covers two bottle sizes: 4 FL. oz. (118 mL) bottles (NDC 0904-1985-20) and One Pint (473 mL) bottles (NDC 0904-1985-16). The product was distributed to 9 distributors, direct accounts, and relabelers who may have further distributed the product throughout the United States.

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 further instructions.

The recalled product

Product
Children's Mapap Acetaminophen Liquid, Fever reducer, Pain reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen 160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC 0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-1985-16, Distributed by Major Pharmaceuticals, L
Manufacturer
Torrent Pharma Inc
Category
Drug — Pediatric OTC
Hazard
Affected units
2,646,228

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) 17E003
  • 17E038
  • Exp. 05/2019
  • 17F002
  • 17F005
  • 17F007
  • 17F025
  • Exp. 06/2019
  • 17G014
  • Exp. 07/2019
  • 17H015
  • Exp. 08/2019
  • 17J004
  • 17J006
  • 17J016
  • Exp. 09/2019
  • 17K008
  • 17K013
  • 17K021
  • 17K027

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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