CLASS II Drug recall · Reported 14 Feb 2024 · FDA Enforcement Report
Skin Protectant, Skin Protectant Gel 10* recalled by OMEZA
Omeza is recalling Skin Protectant, Skin Protectant Gel 10*, distributed nationwide in the US. The recall was initiated on 19 Jan 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0289-2024
- FDA event ID
- 93847
- Recalling firm
- Omeza, Sarasota, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2024
- FDA classified
- 4 Feb 2024
- Reported
- 14 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Jan 2024 | Recall initiated by company | |
| 4 Feb 2024 | Classified by FDA | +16 days |
| 14 Feb 2024 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot: 19123 4-1, Exp. 05/11/2024
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93847| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lidocaine Lavage pain relief oil 10* recalled by OMEZA | Omeza | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Omeza
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Lavage pain relief oil 10* recalled by OMEZA | Omeza | Manufacturing (CGMP) Deviations | Nationwide |