RecallHawk
Class II Recall

AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) PREMIER RESEARCH LABS UPC Code: 807735

Premier Research Labs LLC

Summary

The FDA issued a Class II for AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) by Premier Research Labs LLC. Reason: Product spoiling over time; spoilage visible beneath lid/closure upon opening..

Details

Source

Food Recall

External ID

F-1418-2022

Action Date

2022-07-20

Status

Terminated

Category

food

Product Description

AloePro Dietary Supplement Made With Organic ALOE VERA LIQUID 16 FL Oz. (475 mL) PREMIER RESEARCH LABS UPC Code: 80773500137 packaged in plastic HDPW bottles

Lot/Code Info: Lot 122121-0137 FCE#20921, Item Number 0137,

Quantity Affected: 6,784 units

Reason for Recall

Product spoiling over time; spoilage visible beneath lid/closure upon opening.

Distribution

Nationwide throughout the US

Type: Voluntary: Firm initiated

Recall Initiated: 2022-06-15

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 41 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Premier Research Labs LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Premier Research Labs LLC have FDA actions?

This is the only FDA action we have on record for Premier Research Labs LLC in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-1418-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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