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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- The Aloe Source
- Category
- Drug — Topical Analgesic
- Hazard
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.
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