Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Prevantics
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
Affected NDCs
10819-1080-01
10819-1080-02
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Prevantics Swab Chlorhexidine Gluconate and Isopropyl Alcohol NDC 10819-1080 |
CHLORHEXIDINE GLUCONATE 31.5 mg/mL; ISOPROPYL ALCOHOL .7 mL/mL | Solution Topical |
Professional Disposables International, Inc. | OTC |
- Recalling firm
- Professional Disposables International, Inc.
- NDC code
- 10819-1080-1
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0571-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Alcohol recalls
See all
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Other recalls by Professional Disposables International, Inc.
All 2022 recalls
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
Prevantics
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Class II · Moderate risk
PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick
SubPotent: Out of Specification
Class II · Moderate risk
PDI Povidone-Iodide Cleansing Scrub Swabstick
SubPotent: Out of Specification
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