DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement
Summary
The FDA issued a Class II for DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/ by Golden Lab LLC. Reason: Undeclared fish allergen.
Details
Source
Food Recall
External ID
F-0352-2022
Action Date
2021-12-29
Status
Terminated
Category
food
Product Description
DoctoRx's Optimal Formula, Dry Eye Formula, Ocular Support Softgel, 60 Softgels/Dietary Supplement
Lot/Code Info: Lots: D93210669 and E11290344
Quantity Affected: 13,079 units
Reason for Recall
Undeclared fish allergen
Distribution
Domestic distribution only.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-30
Company
Jacksonville, FL
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 75 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 (Golden Lab LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Golden Lab LLC have FDA actions?
This is the only FDA action we have on record for Golden Lab LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0352-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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