Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Novacort Gel Sample Packets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug: Out of specification result for pramoxine hydrochloride
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What 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
Affected NDCs
69646-0704-01
69646-0704-38
Compare with the code on your package — it is the most precise check available.
Drug: Hydrocortisone
- Recalling firm
- Novum Pharma, LLC
- NDC code
- 69646-704-38
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0433-2017 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrocortisone recalls
See all
Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Class III · Low risk
Essential Calming Skin Gel
Subpotent Drug
Class III · Low risk
Skin Rehab
Subpotent Drug
Class III · Low risk
Remedy Gel
Subpotent Drug
Other wrong potency / content recalls from 2016
All wrong potency / content recalls
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug; out of specification results for assay (manufacturer)
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Subpotency: due to a low, out of specification test result for assay during stability testing.
Class III · Low risk
Aripiprazole Tablets
Superpotent Drug: Product may not meet specifications throughout shelf life.
Class III · Low risk
Donepezil Hydrochloride Tablets
Subpotent Drug: out of specification results for assay test.
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