Pharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tablets, white bottle, NSE Products Inc., Provo, UT 84601 1-888
Summary
The FDA issued a Class II for Pharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tablets, white bottle, by NSE Products, Inc.. Reason: Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredien.
Details
Source
Food Recall
External ID
F-0095-2022
Action Date
2021-11-10
Status
Terminated
Category
food
Product Description
Pharmanex Kids Jungamals, Dietary Supplement 90 Chewable Tablets, white bottle, NSE Products Inc., Provo, UT 84601 1-888-PHARMANEX
Lot/Code Info: Batch Code: CS11711; Expiration Date: April 30, 2022
Quantity Affected: 470 bottles
Reason for Recall
Pharmanex Jungamals was found to have a missing fish allergen statement on the label due to fish gelatin as a sub-component of the Vitamin E ingredient.
Distribution
Distributed directly to consumers nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
Provo, UT
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 54 food recalls issued in the same week, part of 204 food-related FDA actions this month.
NSE Products, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (NSE Products, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NSE Products, Inc. have FDA actions?
NSE Products, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0095-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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