RecallHawk

Summary

CPSC recall: Kroger Acetaminophen, 100 count bottles. By Sun Pharmaceutical Industries Inc., of Princeton, New Jersey. Hazard: The recalled over-the-counter product contains the regulated substance acetaminophen which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.. Remedy: Consumers should immediately store the recalled

Details

Source

CPSC Consumer Product Recall

External ID

9328

Action Date

2022-06-16

Status

Recalled

Category

consumer_product

Product Description

This recall involves the Kroger brand acetaminophen over-the-counter drug. The red, white and gray label states Kroger,

Context & Analysis

This is a unclassified recall.

This was one of 17 consumer_product recalls issued in the same week, part of 47 consumer_product-related FDA actions this month.

Sun Pharmaceutical Industries Inc., of Princeton, New Jersey has 2 FDA actions in our database, including 1 recall.

Frequently Asked Questions

What is a FDA recall?

A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.

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 (Sun Pharmaceutical Industries Inc., of Princeton, New Jersey) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Sun Pharmaceutical Industries Inc., of Princeton, New Jersey have FDA actions?

Sun Pharmaceutical Industries Inc., of Princeton, New Jersey has 2 FDA actions in our database, including 1 recall and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "9328" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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