The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0793-2023·Announced 2023-06-07

Cimetidine HCl Oral Solution Recalled Due to Manufacturing Compliance Deviations

Akorn, Inc. is recalling all lots of Cimetidine HCl Oral Solution 300mg/5mL nationwide due to CGMP deviations. The firm ceased operations and could not 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 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: FDA Class II recall due to CGMP deviations and incomplete stability studies. No illnesses or injuries have been reported. The hazard is precautionary and theoretical rather than an identified contamination or defect.

Plain-English summary

Akorn, Inc. is recalling Cimetidine HCl Oral Solution 300mg/5mL in 237 mL bottles (Rx only) distributed nationwide in the USA and Puerto Rico. All lot numbers are included in this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the required stability studies necessary to ensure the product's safety and efficacy.

Patients currently taking this medication should consult their healthcare provider immediately to discuss alternatives or next steps. Do not stop taking the medication without speaking to a doctor. Pharmacies and healthcare facilities should identify and quarantine all affected product.

The recalled product

Product
Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles, Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Oral Solution
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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