American Health Packaging recalls Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Pack…

Recall date

May 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1293-2020

FDA classification

Class II

Brand / firm

American Health Packaging

Sold / distributed

USA Nationwide

Why it was recalled

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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