The Recall Desk
HighFDA (Drugs)·D-0790-2021·Announced 2021-09-08

Topical Pain Relief AULIEF Recalled for Facility Contamination Risk

China Gel Inc is recalling AULIEF topical pain relief (menthol and camphor) because the product was manufactured in a facility where Burkholderia cepacia contamination was found in other products.

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: This is an FDA Class II recall involving a pathogenic contamination risk (Burkholderia cepacia) at the manufacturing facility. Although no illnesses have been reported and the hazard is facility-based rather than confirmed in the product itself, B. cepacia is an opportunistic pathogen that can cause serious respiratory infections in immunocompromised individuals, warranting a High severity rating.

Plain-English summary

China Gel Inc is recalling AULIEF (Menthol and Camphor) topical pain relief in three package sizes: 3.2 oz tubes, 7.0 oz tubes, and 16 oz bottles with pump. All affected units are from Lot B136HN with expiration 05/2021.

The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. Specifically, the product was manufactured in the same facility where Burkholderia cepacia contamination was detected in other products.

Approximately 3,458 units were distributed nationwide in the USA as well as internationally to Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, and the United Kingdom.

Consumers who have purchased AULIEF should discontinue use and contact China Gel Inc or their healthcare provider for further guidance.

The recalled product

Product
AULIEF (MENTHOL AND CAMOHOR)
Brand
AULIEF
Manufacturer
China Gel Inc
Category
Drug — Topical OTC Pain Relief
Hazard
Affected units
3,458

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 (4)

  • Lot #: a) B136HN
  • Exp 05/2021
  • b) B136HN
  • c) B136HN

UPCs (3)

  • 687806300031
  • 687806300079
  • 687806300161

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by China Gel 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 3 products in this recall →

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