The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1342-2019·Announced 2019-06-19

Chiesi Recalls Zileuton Extended-Release Tablets Due to Dissolution Failure

Chiesi USA is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, because they failed dissolution specifications.

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 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 II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or acute injury risk.

Plain-English summary

Chiesi USA, Inc. is recalling 2,598 bottles of Zileuton Extended-Release Tablets, 600 mg, 120-count bottles. The product is distributed by Prasco Laboratories in Mason, Ohio, and is available by prescription only. The recall covers lot 3171856 with an expiration date of 12/19.

The recall was initiated because the product failed to meet dissolution specifications. Dissolution is a test that measures how quickly a tablet breaks down and releases its active ingredient in the body. When this specification is not met, the medication may not work as intended.

The affected product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment.

The recalled product

Product
Zileuton Extended-Release Tablets, 600 mg, 120-count bottles, Rx only, Distributed by: Prasco Laboratories, Mason, OH 45040 USA; NDC 66993-485-32.
Manufacturer
Chiesi USA, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
2,598

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)

  • Lots: 3171856
  • Exp. 12/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Chiesi USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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