CLASS II Drug recall · Reported 15 Mar 2023 · FDA Enforcement Report
Unguentine Original Maximum Strength Pain recalled by Ecometics
Ecometics is recalling Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 0%, distributed nationwide in the US. The recall was initiated on 24 Feb 2023 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-0452-2023
- FDA event ID
- 91719
- Recalling firm
- Ecometics, Norwalk, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2023
- FDA classified
- 8 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Feb 2023 | Recall initiated by company | |
| 8 Mar 2023 | Classified by FDA | +12 days |
| 15 Mar 2023 | Published in enforcement report | +7 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
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 0% recalled?
Yes. Ecometics recalled Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 0% on 24 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0452-2023.
Why was it recalled?
CGMP DEVIATIONS
Which lots are affected?
Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24
Where was it sold?
Nationwide within the United States
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ecometics
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Yager's Liniment (Camphor and Turpentine Oil) recalled by Ecometics | Ecometics | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Unguentine Ointment, (Camphor 0%, Phenol 5%, Tannic Acid recalled | Ecometics | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Blis-To-Sol Liquid (Tolnaftate) recalled by Ecometics | Ecometics | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alcolado Relampago (Menthol and Camphor), 1% and 5% respectively recalled | Ecometics | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g recalled by Ecometics | Ecometics | Manufacturing (CGMP) Deviations | Nationwide |