Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case
Summary
The FDA issued a Class II for Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 car by The Procter & Gamble Company. Reason: Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store..
Details
Source
Food Recall
External ID
F-1012-2022
Action Date
2022-05-04
Status
Terminated
Category
food
Product Description
Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case
Lot/Code Info: Lot No. 1022171991 Product No. 80347747 Best By Date: 07/31/2022
Quantity Affected: 23,928 cartons
Reason for Recall
Product failed micro testing. Firm sent product for destruction, but was redirected for sale through online store.
Distribution
Product was sent to a 3rd party for destruction due to not meeting micro specs
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-24
Company
Cincinnati, OH
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 29 food recalls issued in the same week, part of 204 food-related FDA actions this month.
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls.
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 (The Procter & Gamble Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Procter & Gamble Company have FDA actions?
The Procter & Gamble Company has 27 FDA actions in our database, including 27 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1012-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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