Akorn, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufac…

Recall date

October 29, 2018

Source

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

Recall number

D-1208-2019

FDA classification

Class III

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60