The Recall Desk
SevereFDA (Drugs)·D-1883-2019·Announced 2019-10-09

Akorn Recalls Phenylephrine Ophthalmic Solution Due to Sterility Concerns

Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, 2.5%, due to out-of-specification container closure test results that cannot guarantee sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.

Plain-English summary

Akorn, Inc. is recalling 60,176 bottles of Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle (NDC 17478-201-15). The recall is being conducted because out-of-specification results for the container closure test mean the sterility of the product cannot be guaranteed.

The affected product is identified by Lot # 031908A with an expiration date of 03/20. The product was distributed nationwide in the USA and Puerto Rico.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
60,176

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 (2)

  • Lot #: 031908A
  • Exp 03/20

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Akorn, Inc.

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Same hazard · sterility failure

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