Why it was recalled
Subpotent Drug: Out of specification result for pramoxine hydrochloride
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
Lot numbers, UPCs & expiration codes
Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0433-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 7, 2016
- FDA report date
- Jan 25, 2017
- Quantity
- 6,763 1 gram sample packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novum Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0433-2017, exactly as published.
Show all FDA fields
- City
- Chicago
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 76233
- Address
- Suite 670
- Address (line 2)
- 640 N. Lasalle Street
- Code information
- Lot: 8249 - Exp. Date: 03/18 Lot: 8250 - Exp. Date: 06/18
- Postal code
- 60654
- Report date
- Jan 25, 2017
- Product type
- Drugs
- Recall number
- D-0433-2017
- Classification
- Class III
- Recalling firm
- Novum Pharma, LLC
- Product quantity
- 6,763 1 gram sample packets
- Termination date
- Apr 8, 2019
- Reason for recall
- Subpotent Drug: Out of specification result for pramoxine hydrochloride
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 7, 2016
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2017