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, Chic

FDA recall notice · announced January 25, 2017 · Novum Pharma

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Reason for recall

Subpotent Drug: Out of specification result for pramoxine hydrochloride

Notes

Distribution: Nationwide
Lot/code information: Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
Quantity: 6,763 1 gram sample packets
Status: Terminated
Products in this recall event:
- 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 (D-0433-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.