The Recall Desk
ModerateFDA (Devices)·Z-1968-2019·Announced 2019-07-24

Pharmaceutical Innovations Recalls Alpha Conducting Solution for Antimicrobial Testing Failure

Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution due to potential failure in stability antimicrobial effectiveness testing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is theoretical (potential for failed testing), which limits the score to at most 3. Given the lack of reported harm and the nature of the defect, it is rated as Moderate.

Plain-English summary

Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution, an electrode conductivity spray solution, due to a potential for failed stability antimicrobial effectiveness testing. The recall involves product codes 3310-15 ACS.

The affected lots are 081914-15, 111715-15, 070116-15, 020117-15, 080117-15, 010118-15, 041618-15, 041618A-15, 071618-15, and 102018-15. A total of 87,140 units were distributed. The product was distributed nationwide in the United States, including Arizona, California, Connecticut, Florida, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Tennessee, Vermont, and West Virginia. It was also distributed internationally to accounts in Australia, France, Germany, Hong Kong, Saudi Arabia, and Canada.

The source text does not specify specific instructions for consumers or healthcare providers regarding the disposition of the product. No illnesses or injuries are reported in the source text.

The recalled product

Product
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
Manufacturer
Pharmaceutical Innovations, Inc.
Category
Medical Device — Electrode Conductivity Solution
Hazard
Affected units
87,140

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 (10)

  • Lot # 081914-15
  • 111715-15
  • 070116-15
  • 020117-15
  • 080117-15
  • 010118-15
  • 041618-15
  • 041618A-15
  • 071618-15
  • 102018-15

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Pharmaceutical Innovations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · Pharmaceutical Innovations, Inc.

See all →

Same hazard · antimicrobial failure

See all →