FDA Recall D-0494-2017
Jeffreys Drug Store · Canonsburg, PA
Class I — life-threatening Terminated 705 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Reason for recall
Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Recall record
- Recall number
D-0494-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- PA
- Recall initiated
- 2016-11-23
- Classified by FDA Center
- 2017-02-27
- FDA published
- 2017-03-08
- Terminated
- 2018-10-29
- Recalling firm
- Jeffreys Drug Store
- Firm location
- Canonsburg, PA