Drug 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
D-1208-2019
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 81426
- Status
- Terminated
- Classification
- Class III
- Quantity
- 58,393 jars
- Official record key
drug-enforcement:D-1208-2019
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
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.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification