Absorica Capsules recalled over undeclared excipients

Recall date

June 26, 2015

Source

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

Official notice title

Ranbaxy Inc. recalls Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY…

Recall number

D-1288-2015

FDA classification

Class II

Brand / firm

Ranbaxy Inc.

Sold / distributed

Nationwide

Why it was recalled

Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.

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

What was recalled

Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31.