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
Reported: January 25, 2017 Initiated: December 7, 2016 #D-0433-2017
Product Description
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
Details
- Recalling Firm
- Novum Pharma, LLC
- Units Affected
- 6,763 1 gram sample packets
- Distribution
- Nationwide
- Location
- Chicago, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novum Pharma, LLC. Units affected: 6,763 1 gram sample packets.
Why was this product recalled? ▼
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2017. Severity: Low. Recall number: D-0433-2017.
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