OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is a FDA Class III recall involving a labeling defect. The issue is limited to incorrect or missing lot and expiration date information, with no reported illnesses, injuries, or adverse events. Per the rubric, FDA Class III recalls are typically scored 1–2; minor labeling errors fall under Score 2.
Plain-English summary
Akron Pharma, Inc. is recalling Dibucaine 1% Hemorrhoidal Ointment tubes due to a labeling defect. The affected product is Lot #2206016 with an expiration date of May 2024. The recall covers 4,416 tubes.
The labeling on the product contains incorrect or missing lot number and expiration date information. This labeling issue prevents proper product identification and traceability.
The affected product was distributed nationwide within the United States. Consumers who have this product should verify the lot number and expiration date on their package against the recalled lot information.
The recalled product
- Product
- DIBUCAINE (DIBUCAINE)
- Brand
- DIBUCAINE
- Manufacturer
- Akron Pharma, Inc.
- Category
- Drug — Topical OTC
- Hazard
- Affected units
- 4,416
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)
- Lot #: 2206016
- Exp. date 05/2024
Distribution
Distributed nationwide across the United States.
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