The Recall Desk
HighFDA (Devices)·Z-1972-2019·Announced 2019-07-24

Pharmaceutical Innovations Recalls Alpha Conducting Solution Due to Stability Testing Concerns

Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution due to potential failures in stability antimicrobial effectiveness testing. The product was distributed in the US and internationally.

What this means for you

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: The recall is classified as FDA Class II. The hazard involves potential antimicrobial failure, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Pharmaceutical Innovations, Inc. is recalling Alpha Conducting solution, an Electrode Conductivity Spray Solution. The recall is being conducted because of a potential for failed stability antimicrobial effectiveness testing. The affected product codes are 3310-25 ASCR.

The recalled lots include 032014-25, 060515-25, 101615-25, 011716-25, 021317-25, 080117-25, 010118A-25, 041618-25, 071618-25, and 102018A-25. The product was distributed nationwide in the United States, including in 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.

This recall is classified as Class II by the FDA. Users should stop using the product and contact the manufacturer for further instructions.

The recalled product

Product
Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
Manufacturer
Pharmaceutical Innovations, Inc.
Category
Medical Device — Electrode Conductivity Solution
Hazard

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 # 032014-25
  • 060515-25
  • 101615-25
  • 011716-25
  • 021317-25
  • 080117-25
  • 010118A-25
  • 041618-25
  • 071618-25
  • 102018A-25

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.

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Same hazard · antimicrobial failure

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