Class III
Terminated
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
This recall has been terminated (originally issued January 25, 2017).
- Company
- Novum Pharma, Llc
- Recall Initiated
- December 7, 2016
- Posted
- January 25, 2017
- Recall Number
- D-0433-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,763 1 gram sample packets
- Firm Location
- Chicago, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Distribution
Nationwide
Lot / Code Info
Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
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