CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads recalled

Mckesson Medical-Surgical Inc. Corporate Office is recalling Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart# 1116
NDC67777-121
UPC0840117333307, 0840117333321, 0840117333345
Quantity recalled10 boxes

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1326-2022
FDA event ID
90553
Manufacturer
Dynarex Corporation
Classification
Class II
Status
Terminated
Recall initiated
29 Jun 2022
FDA classified
5 Aug 2022
Reported
17 Aug 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

29 Jun 2022Recall initiated by company
5 Aug 2022Classified by FDA+37 days
17 Aug 2022Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: products were stored outside the drug label specifications.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.

Where it was distributed

Nationwide in the USA.

Nationwide

Questions about this recall

Is Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per recalled?

Yes. Mckesson Medical-Surgical Inc. Corporate Office recalled Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per on 29 Jun 2022. The recall is Class II and its status is Terminated. Recall number D-1326-2022.

Why was it recalled?

CGMP Deviations: products were stored outside the drug label specifications.

Which lots are affected?

Part# 1116

Where was it sold?

Nationwide in the USA.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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