FDA Drug recall D-0494-2017
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave
- FDA Drug
- Class I
- terminated
- Published 2017-03-08
On 2017-03-08 the FDA classified a Class I recall of Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave by Jeffreys Drug Store, citing marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0494-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-11-23 |
| Published | 2017-03-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Jeffreys Drug Store |
| Distribution | PA |
Product
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Reason
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Identifiers
| code_info | Lot #: 071116-103323, Exp. Date 1/7/2017 |
|---|
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-0494-2017%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.