FDA recall D-1582-2019

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-08-01

Report date

2019-08-07

Termination date

2020-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1582-2019