Recalls / Class III
Class IIID-1208-2019
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
- Affected lot / code info
- 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.
Why it was recalled
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1222 W Grand Ave, N/A, Decatur, Illinois 62522-1412
Distribution
- Quantity
- 58,393 jars
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-10-29
- FDA classified
- 2019-04-23
- Posted by FDA
- 2018-12-05
- Terminated
- 2022-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1208-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.