D-1208-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 5, 2018
- Initiation Date
- October 29, 2018
- Termination Date
- August 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.