Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Ciclopirox Olamine Cream USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Affected NDCs
0713-0638-15
0713-0638-18
0713-0638-31
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 Olamine NDC 00713-0638 |
7.7 mg/g | Cream Topical |
Cosette Pharmaceuticals, Inc. | Rx |
- Recalling firm
- G & W Laboratories, Inc.
- NDC code
- 0713-0638-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0250-2018 · 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 shampoo 1%
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
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 G & W Laboratories, Inc.
All 2018 recalls
Class III · Low risk
G & W Clobetasol Propionate Ointment 0.05%
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Class III · Low risk
Ciclopirox Olamine Cream USP
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots.
Class II · Moderate risk
Indocin (Indomethacin)
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
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