PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 5, 2018 Initiated: October 29, 2018 #D-1208-2019

Product Description

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

Details

Recalling Firm
Akorn, Inc.
Units Affected
58,393 jars
Distribution
Nationwide USA and Puerto Rico
Location
Decatur, IL

Frequently Asked Questions

What product 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. Recalled by Akorn, Inc.. Units affected: 58,393 jars.
Why was this product recalled?
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Which agency issued this recall?
This recall was issued by the FDA Drug on December 5, 2018. Severity: Low. Recall number: D-1208-2019.