FDA Drug recall D-0512-2019
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
- FDA Drug
- Class III
- terminated
- Published 2019-02-27
On 2019-02-27 the FDA classified a Class III recall of Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09 by Perrigo New York, citing failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0512-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-13 |
| Published | 2019-02-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Perrigo New York |
| Distribution | US |
Product
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Reason
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Identifiers
| ndc | 45802-401-09 |
|---|---|
| code_info | Lot #: 7DT0280, 7ET0565, Exp. 02/19 |
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-0512-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.