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
- bacterial-contamination
- b-cepacia
- manufacturing-deficiency
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.
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