FDA Drug recall D-0636-2017
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…
- FDA Drug
- Class III
- terminated
- Published 2017-04-12
On 2017-04-12 the FDA classified a Class III recall of 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(NDC… by G And W Laboratories, citing labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0636-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-20 |
| Published | 2017-04-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | G And W Laboratories |
| Distribution | US |
Product
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 Plainfeld, NJ 07080.
Reason
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.
Identifiers
| ndc | 0713-0638-15 |
|---|---|
| ndc | 0713-0638-31 |
| ndc | 0713-0638-18 |
| code_info | Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 638…Lot #: a) 63800090, Exp 04/17; 63800095, Exp 11/17; 1000573, Exp 02/18; 1002560, Exp 06/18; b) 63800090, Exp 04/17; 63800092, Exp 07/17; 63800093, Exp 08/17; 63800095, Exp 11/17; 1000574, Exp 02/18; 1001772, Exp 05/18; c) 63800089, Exp 03/17; 63800091, Exp 07/17; 63800094, Exp 08/17; 1000842, Exp 01/18; 1000966, Exp 03/18; 1001771, Exp 05/18; 1002562, Exp 06/18. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0636-2017%22
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