CLASS II Drug recall · Reported 25 Nov 2015 · FDA Enforcement Report
Dexamethasone 4% Opth Ointment ointment tubes recalled
Kalman Health & Wellness is recalling Dexamethasone 4% Opth Ointment ointment tubes, distributed nationwide in the US. The recall was initiated on 3 Sep 2015 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-303-2016
- FDA event ID
- 72241
- Recalling firm
- Kalman Health & Wellness, Peoria, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2015
- FDA classified
- 17 Nov 2015
- Reported
- 25 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 3 Sep 2015 | Recall initiated by company | |
| 17 Nov 2015 | Classified by FDA | +75 days |
| 25 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Where it was distributed
Nationwide
Questions about this recall
Is Dexamethasone 4% Opth Ointment ointment tubes recalled?
Yes. Kalman Health & Wellness recalled Dexamethasone 4% Opth Ointment ointment tubes on 3 Sep 2015. The recall is Class II and its status is Terminated. Recall number D-303-2016.
Why was it recalled?
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Which lots are affected?
Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/2015
Where was it sold?
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 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 Kalman Health & Wellness
All 39| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin 30 mg/mL PF Injection prefilled syringes recalled | Kalman Health & Wellness | Sterility | Nationwide |
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