Class II · Moderate risk
C-Urea 40% Bladder Instill
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Carbo-O-Philic 40 Gel 40%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Cause type: Unapproved drug
The product was marketed without an approved NDA/ANDA, or does not meet the OTC monograph it claims to follow. Nothing about the product - dose, purity, safety - has been reviewed by FDA, so the claims on the box are unverified. All unapproved drug recalls.
What was recalled
Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
Affected NDC
54162-0016-15
Compare with the code on your package — it is the most precise check available.
Drug: Urea
- Recalling firm
- Geritrex Corp
- NDC code
- 54162-016-15
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0391-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Urea recalls
See all
Class II · Moderate risk
UREA 40% Cream
Lack of Assurance of Sterility: There are also CGMP Deviations.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
Class II · Moderate risk
All Germall
Lack of Processing Controls
Other recalls by Geritrex Corp
All 2015 recalls
Class II · Moderate risk
Preferred Plus Dioctyl Liquid Stool Softener
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Gericare Geri-Tussin DM
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Ritussin DM Double Strength
cGMP Deviations: Products may have microbial contamination.
Class II · Moderate risk
Preferred Plus Pharmacy Iron Elixir Ferrous Sulfate
cGMP Deviations: Products may have microbial contamination.
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