Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Ciclopirox shampoo 1%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Affected NDC
45802-0401-09
Compare with the code on your package — it is the most precise check available.
Drug: Ciclopirox
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 |
|---|---|---|---|---|
| Ciclopirox NDC 45802-0401 |
1 g/100mL | Shampoo Topical |
Padagis Israel Pharmaceuticals Ltd | Rx |
- Recalling firm
- Perrigo New York, Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0512-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Ciclopirox recalls
See all
Class III · Low risk
Ciclopirox Gel 0.77%
Defective Container: Firm received complaints of broken tube at the seal.
Class II · Moderate risk
Ciclopirox Topical Solution 8%
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Other recalls by Perrigo New York, Inc.
All 2019 recalls
Class II · Moderate risk
Hydrocortisone Ointment
Failed Stability Specifications
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