D-0494-2017 Class I Terminated
FDA drug recall D-0494-2017 was initiated by Jeffreys Drug Store on November 23, 2016 and is designated Class I. Reason for recall: Marketed without an approved NDA/ANDA for which safety and efficacy has not been established. The recall status is terminated (terminated October 29, 2018). Affected quantity: 9 - 30 day scripts.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- November 23, 2016
- Termination Date
- October 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 - 30 day scripts
Product Description
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.
Distribution Pattern
PA
Code Information
Lot #: 071116-103323, Exp. Date 1/7/2017