FDAClass IIIJanuary 25, 2017

Novacort Gel Sample Packets recall: Subpotent

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…

Why was Novacort Gel Sample Packets recalled?

Subpotent Drug: Out of specification result for pramoxine hydrochloride

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18

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…
Recalling firm
Novum Pharma, LLC
Quantity
6,763 1 gram sample packets
Distribution
Nationwide
Recall date
January 25, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls