The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0949-2016·Announced 2016-06-08

Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns

Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection.

Plain-English summary

Akorn, Inc. is recalling 57,920 bottles of Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles (NDC 17478-221-12). The recall involves three specific lots: Lot# 5A17A (Expiry 06/16), Lot# 5K21A (Expiry 03/17), and Lot# 6A08A (Expiry 06/17). The product was distributed nationwide and in Puerto Rico.

The recall was initiated due to a lack of assurance of sterility. Specifically, some lots failed Antimicrobial Effectiveness Testing on stability. This testing failure suggests that the preservative system may not be effective in maintaining the sterility of the product over time.

Consumers and healthcare providers should stop using the affected lots immediately. Patients should consult their healthcare provider for alternative treatment options. The recalling firm is Akorn, Inc., located in Lake Forest, IL.

The recalled product

Product
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic
Hazard
Affected units
57,920

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 (4)

  • Lot# 5A17A
  • Expiry 06/16 Lot# 5K21A
  • Expiry 03/17 Lot# 6A08A
  • Expiry 06/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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