The Recall Desk
HighFDA (Drugs)·D-0916-2018·Announced 2018-07-18

Akorn Recalls Acetylcysteine for Injection Due to Manufacturing Deviations

Akorn, Inc. is recalling 89,507 vials of Acetylcysteine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is classified as FDA Class II.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or fatalities, placing this in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is voluntarily recalling 89,507 vials of Acetylcysteine for Injection 6 g/30 mL (200 mg/mL), NDC 17478-660-30. The recall was initiated on June 22, 2018, and was classified as FDA Class II on July 9, 2018. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.

The affected lots are 061496A (Exp. 06/2018), 111696A (Exp. 11/2018), 061947A (Exp. 06/2019), and 091267A (Exp. 09/2019). The product was distributed nationwide in the United States. The recall status is currently Terminated, with a termination date of November 6, 2020.

Healthcare providers and patients should check their inventory for these specific lot numbers and expiration dates. If you have this product, contact your healthcare provider or pharmacist for instructions on how to dispose of or return the medication. Do not use the recalled product.

The recalled product

Product
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Manufacturer
Akorn, Inc.
Category
Drug — Injectable Medication
Hazard
Affected units
89,507

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 (8)

  • Lots: 061496A
  • Exp. 06/2018
  • 111696A
  • Exp. 11/2018
  • 061947A
  • Exp. 06/2019
  • 091267A
  • Exp. 09/2019

Distribution

Distributed nationwide across the United States.

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Same hazard · cgmp deviations

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