West-Ward Columbus Inc recalls Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 01…

Recall date

May 13, 2020

Source

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

Recall number

D-1274-2020

FDA classification

Class II

Brand / firm

West-Ward Columbus Inc

Sold / distributed

USA Nationwide

Why it was recalled

Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.

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, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.