PlainRecalls
FDA Drug Moderate Class II Terminated

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

Reported: August 7, 2019 Initiated: August 1, 2018 #D-1582-2019

Product Description

Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11

Reason for Recall

Failed Dissolution Specifications: Out of specification result for the dissolution test.

Details

Recalling Firm
American Health Packaging
Units Affected
6,579 cartons
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit Dose Blisters), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217, NDC Carton: 62584-693-21; NDC Unit Dose: 62584-693-11. Recalled by American Health Packaging. Units affected: 6,579 cartons.
Why was this product recalled?
Failed Dissolution Specifications: Out of specification result for the dissolution test.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 7, 2019. Severity: Moderate. Recall number: D-1582-2019.