FDA recall D-1026-2018

MAJOR PHARMACEUTICALS · Class II · drug

Product

Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-0430-04

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2018-07-30
Report date
2018-08-08
Termination date
2019-12-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1026-2018