Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0446-2022·Announced 2022-02-02

Promethazine HCl Topical Ointment Recalled for CGMP Deviations

Edge Pharma, LLC is recalling Promethazine HCl Topical Ointment, 2.5% due to CGMP (Current Good Manufacturing Practice) deviations. The voluntary nationwide recall affects approximately 7,788 syringes distributed across multiple lots.

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 source text identifies this as an FDA Class II recall due to CGMP deviations. The source explicitly states no illnesses or injuries were reported; the hazard is manufacturing compliance-related rather than a documented safety event. This qualifies as a precautionary manufacturing-based recall appropriate for a Moderate severity score.

Plain-English summary

Edge Pharma, LLC, located in Colchester, Vermont, is voluntarily recalling Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), supplied in 1.2 mL single-dose syringes for topical use. The product is identified by NDC 05446-1341-01.

The recall was initiated on December 6, 2021, due to CGMP (Current Good Manufacturing Practice) deviations identified by the manufacturer. Approximately 7,788 syringes have been distributed nationwide across five production lots with codes 08-2021-02@9, 08-2021-16@10, 09-2021-08@6, 09-2021-20@6, and 10-2021-18@6, with respective dates of December 15, 2021, December 29, 2021, January 21, 2022, February 2, 2022, and March 2, 2022.

Consumers should discontinue use of this product and consult with their healthcare provider regarding appropriate alternatives. Healthcare providers and dispensing pharmacies should quarantine remaining stock. The FDA classified this as a Class II recall, and the firm initiated the recall voluntarily on December 6, 2021. The recall status is terminated as of June 7, 2023.

The recalled product

Product: Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01
Manufacturer: Edge Pharma, LLC
Category: Drug — Topical Ointment
Hazard: cgmp-deviation
manufacturing-compliance
Affected units: 7,788

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 (4)

08-2021-02@9 12-15-2021
08-2021-16@10 12-29-2021
09-2021-08@6 01-21-2022
09-2021-20@6 02-02-2022 & 10-2021-18@6 03-02-2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, LLC 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 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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