H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Or
Summary
The FDA issued a Class II for H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with by MEDLINE INDUSTRIES, LP - Northfield. Reason: Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration..
Details
Source
Drug Recall
External ID
D-0603-2025
Action Date
2025-09-03
Status
Ongoing
Category
drug
Product Description
H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China with components from Taiwan, Elaborado Con Orgullo Y Cuidado PARA H-E-B, San Antonio, TX 78204, NDC 37808-809-09.
Lot/Code Info: 61224080041
Quantity Affected: 300000 pads
Reason for Recall
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-07
Company
Northfield, IL
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 42 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 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 (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0603-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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