Alcohol Prep Swab
FDA Recall NDC 67777-121
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Alcohol Prep (NDC 67777-121). A significant event, classified as Class II, was initiated on Jun 29, 2022 by Dynarex Corporation. The reported reason for this action was: "CGMP Deviations: products were stored outside the drug label specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Jun 29, 2022
Aug 17, 2022
10 boxes
Recall Profile & Regulatory Data
Event ID
90553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 13, 2024
Product Description
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
Batch or Lot Expiration Information
Lot# Part# 1116
Affected Packages Involved in this Recall
67777-121-14Product
67777-121-19Product
67777-121-20Product
67777-121-16Product
67777-121-17Product
67777-121-18Product
67777-121-13Product
67777-121-11Product
67777-121-12Product
67777-121-27Product
67777-121-26Product
67777-121-21Product
67777-121-22Product
67777-121-23Product
67777-121-24Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
