FDA Drug recall D-0250-2018
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15)
- FDA Drug
- Class III
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class III recall of Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15) by G And W Laboratories, citing discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0250-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-01-19 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 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 Plainfield, NJ 07080.
Reason
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Identifiers
| ndc | 0713-0638-15 |
|---|---|
| ndc | 0713-0638-31 |
| ndc | 0713-0638-18 |
| code_info | Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 100579…Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0250-2018%22
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