Novum Pharma Recalls Subpotent Novacort Gel Sample Packets
Novum Pharma is recalling Novacort Gel sample packets because the pramoxine hydrochloride content was found to be out of specification.
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: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences, aligning with the Moderate severity score for minor labeling or specification errors.
Plain-English summary
Novum Pharma, LLC is recalling Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl). The affected products are 1.0 g sample packets sold in 10-count cartons, identified by NDC 69646-704-38 and NDC 69646-704-01. The recall involves 6,763 sample packets distributed nationwide.
The recall was initiated because the product failed to meet specifications for pramoxine hydrochloride, resulting in a subpotent drug. The affected lots are 8249 (expiration date 03/18) and 8250 (expiration date 06/18).
Consumers and healthcare providers should stop using the affected Novacort Gel sample packets and contact their pharmacist or Novum Pharma for further instructions.
The recalled product
- Product
- Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654
- Manufacturer
- Novum Pharma, LLC
- Category
- Drug — Topical Steroid
- 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)
- Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
Distribution
Distributed nationwide across the United States.
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