The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1208-2019·Announced 2018-12-05

Akorn Recalls Clindamycin Phosphate Topical Solution Due to Impurity Failures

Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% because the product failed impurity and degradation specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, and the source text does not report any specific injuries or illnesses.

Plain-English summary

Akorn, Inc. is recalling 58,393 jars of Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar. The product is prescription-only and was manufactured by Ei LLC in Kannapolis, North Carolina. The recall covers specific lots with expiration dates of January 31, 2019, and February 28, 2019.

The recall was initiated because the product failed impurities and degradation specifications, with out-of-specification results observed for other individual impurities. The affected product was distributed nationwide in the United States and in Puerto Rico.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

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
Manufacturer
Akorn, Inc.
Category
Drug — Topical Antibiotic
Hazard
Affected units
58,393

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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