The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0837-2023·Announced 2023-06-07

Promethazine HCl & Codeine Phosphate Oral Solution Recalled Due to Manufacturing Compliance Deviations

Akorn Inc. is recalling all lots of Promethazine HCl & Codeine Phosphate Oral Solution nationwide because 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 is a Class II recall where the firm's closure prevented completion of required stability studies. While no illnesses or injuries have been reported, the inability to verify product stability for a prescription medication represents a risk-of-harm situation under the rubric criteria for Score 3.

Plain-English summary

Akorn Inc. is recalling all lots of Promethazine HCl & Codeine Phosphate Oral Solution, 6.25mg/10mg per 5 mL (Rx only), distributed nationwide in the USA and Puerto Rico. The recall is due to Current Good Manufacturing Practice (CGMP) deviations.

The firm went out of business and could no longer continue stability studies for the product. All National Drug Code (NDC) numbers and all product lots are affected by this recall.

The recalled product

Product
Promethazine HCl & Codeine Phosphate Oral Solution, USP, 6.25mg/10mg per 5 mL, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Prescription Medication
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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