Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Hand Sanitizer Foam
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC 53329-970-08; and c) 16 Oz. (453 g) cans, NDC 53329-970-06; Manufactured for: Medline Industries, Inc., Northfield, IL 60093.
Affected NDCs
53329-0970-06
53329-0970-08
53329-0970-12
Compare with the code on your package — it is the most precise check available.
Drug: Alcohol
- Recalling firm
- Medline Industries Inc
- NDC code
- 53329-970-12
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0287-2022 · 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 Medline Industries Inc
All 2021 recalls
Class III · Low risk
Readyprep Chg
Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Class II · Moderate risk
SparkleFresh Fluoride Toothpaste
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
PVP Scrub Solution
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Class II · Moderate risk
Medline Incision & Drainage Tray
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
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