FDA recall D-1208-2019

Product

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

Reason for recall

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

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2018-10-29

Report date

2018-12-05

Termination date

2022-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Decatur, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1208-2019