Reported Dec 5, 2018 · Terminated

Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only.…

Akorn, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 1222 W Grand Ave · Decatur, IL · 62522-1412

Is this the product you have?

  • 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
Lot codes and dates

9 of 9 products

Products covered by this recall
#Product as published
1Lot# 2530300, Expiration date: 1/31/2019.
2Lot# 2530400, Expiration date: 1/31/2019.
3Lot# 2607300, Expiration date: 1/31/2019.
4Lot# 2607400, Expiration date: 1/31/2019.
5Lot# 2607500, Expiration date: 1/31/2019.
6Lot# 2607600, Expiration date: 1/31/2019.
7Lot# 2615800, Expiration date: 1/31/2019.
8Lot# 2630200, Expiration date: 2/28/2019.
9Lot# 2630300, Expiration date: 2/28/2019.
Amount recalled
58,393 jars

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 9, 2022 · Data as of Sep 19, 8:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.