The Recall Desk
ModerateFDA (Drugs)·D-1053-2016·Announced 2016-07-06

Aloe Source Recalls Topical Analgesic Products Due to Manufacturing Deviations

The Aloe Source is voluntarily recalling specific lots of aloe SPORT liniment and eucalyptus cream due to CGMP deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which aligns with the rubric for moderate severity involving voluntary precautionary recalls or minor labeling/manufacturing errors without reported injuries.

Plain-English summary

The Aloe Source is voluntarily recalling 577 units of aloe SPORT liniment TOPICAL ANALGESIC and ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream. The affected products include 8 fl oz. tubes and bottles of liniment, as well as 1 fl oz. plastic bottles of eucalyptus cream. The recall covers Lot # 1407012 with an expiration date of 03/17.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The products were distributed nationwide. The recall was initiated on May 11, 2016, and was terminated on March 31, 2017.

Consumers with these specific products should stop using them and contact the recalling firm for instructions. The FDA classifies this as a Class II recall, meaning there is a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc., the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295
Manufacturer
The Aloe Source

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 (2)

  • Lot # 1407012
  • Exp. 03/17

Distribution

Distributed nationwide across the United States.

Same hazard · cgmp deviations

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