The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0838-2023·Announced 2023-06-07

Promethazine HCl Oral Solution Recalled Due to Manufacturing Deviations

Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, due to Current Good Manufacturing Practice deviations. The firm went out of business and cannot complete required stability studies.

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 3/5 (High).

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: This FDA Class II recall involves a prescription drug with Current Good Manufacturing Practice deviations and incomplete stability studies. As a risk-of-harm product where no illnesses or injuries have been reported, this meets the criteria for a High severity classification.

Plain-English summary

Akorn, Inc. is recalling all lots of Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles. The product is distributed nationwide in the United States and Puerto Rico by Akorn Operating Company LLC, Gurnee, IL 60031, and is available only by prescription.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer conduct the stability studies required to verify that the product maintains its chemical and physical integrity throughout its shelf life.

All lots of the product are affected by this recall. Stability studies are critical for confirming that a drug maintains its safety, quality, and potency over time. Without completion of these studies, the product cannot be verified to meet regulatory specifications.

Patients currently using this medication should contact their prescribing physician or pharmacist. Those who have unused portions of this product should return it to their pharmacy for proper disposal or follow FDA disposal guidelines.

The recalled product

Product
Promethazine HCl Oral Solution, USP, 6.25 mg/5mL, 473 mL bottles, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, 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 86 products in this recall →

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