aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by:
Check against the official notice below — it lists the full affected range.
China Gel Inc is recalling aulief topical pain relief products due to current Good Manufacturing Practice (CGMP) deviations. The recalled products were manufactured in a facility where contamination with B. cepacia bacteria was found in other products. The recall affects two package sizes: a 3.2 oz tube (UPC 687806300031, NDC 76305-302-01) and a 7.0 oz tube (UPC 687806), both with lot number B136HN and expiration date 05/2021. A total of 3,458 tubes 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.
The source document does not specify what remedy consumers should pursue regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Reason for recall: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products. Distribution: Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom Quantity: 3458 tubes Lot/code info: Lot #: a) B136HN, Exp 05/2021; b) B136HN, Exp 05/2021; c) B136HN, Exp 05/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.