October 2018 FDA Recall Drug by Akorn, Inc.
D-1208-2019 - Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities

This Class III drug recall was voluntarily initiated by Akorn, Inc. on October 29, 2018 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification results observed for other individual impurities. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1208-2019

Reason for Recall
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Initiated
10-29-2018
Reported
12-05-2018
Quantity
58,393 jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81426
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 2530200, Expiration date: 1/31/2019.
Lot# 2530300, Expiration date: 1/31/2019.
Lot# 2530400, Expiration date: 1/31/2019.
Lot# 2607300, Expiration date: 1/31/2019.
Lot# 2607400, Expiration date: 1/31/2019.
Lot# 2607500, Expiration date: 1/31/2019.
Lot# 2607600, Expiration date: 1/31/2019.
Lot# 2615800, Expiration date: 1/31/2019.
Lot# 2630200, Expiration date: 2/28/2019.
Lot# 2630300, Expiration date: 2/28/2019.