D-1208-2019 Class III Terminated
FDA drug recall D-1208-2019 was initiated by Akorn, Inc. on Oct 29, 2018 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities The recall status is terminated (terminated Aug 9, 2022). Affected quantity: 58,393 jars.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 5, 2018
- Initiation Date
- Oct 29, 2018
- Termination Date
- Aug 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58,393 jars
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
Distribution Pattern
Nationwide USA and Puerto Rico
Code 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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1208-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026