PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 8, 2018 Initiated: July 30, 2018 #D-1026-2018

Product Description

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

Details

Recalling Firm
MAJOR PHARMACEUTICALS
Units Affected
3,161 Cartons
Distribution
Nationwide USA
Location
Livonia, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by MAJOR PHARMACEUTICALS. Units affected: 3,161 Cartons.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1026-2018.