The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1326-2022·Announced 2022-08-17

FDA Recalls Sterile Alcohol Prep Pads Due to Improper Storage

Mckesson Medical-Surgical is recalling ALCOHOL PREP sterile alcohol prep pads nationwide because they were stored outside manufacturer specifications, potentially compromising sterility. FDA classified this as a Class II recall.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a sterile medical product where improper storage could compromise sterility assurance. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not been reported, warranting a High severity score.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling ALCOHOL PREP sterile alcohol prep pads (isopropyl alcohol, NDC 67777-121-16) distributed nationwide. The recall affects 10 boxes of sterile, latex-free alcohol prep pads containing 100 large pads per box, part number 1116, manufactured for Dynarex Corporation.

The recall was initiated because the products were stored outside the specifications listed on the drug label, a violation of FDA Current Good Manufacturing Practice (CGMP) requirements. When sterile medical products are stored improperly, the integrity of their sterility assurance may be compromised.

This product was distributed nationwide in the USA. Healthcare facilities, clinics, hospitals, and other settings using these alcohol prep pads may be affected.

Consumers and healthcare providers should discontinue use of the recalled product and contact Mckesson Medical-Surgical Inc. for replacement or return instructions. Check product code Part# 1116 or the NDC 67777-121-16 to verify if your supply is affected.

The recalled product

Product
ALCOHOL PREP (ISOPROPYL ALCOHOL)
Brand
ALCOHOL PREP
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Topical Antiseptic Prep
Hazard
Affected units
10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part# 1116

UPCs (3)

  • 0840117333307
  • 0840117333321
  • 0840117333345

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Related recalls

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

See all →

Same hazard · improper storage

See all →

Similar recalls