CLASS II Drug recall · Reported 12 Mar 2014 · FDA Enforcement Report
Dexamethasone (pf) 05 % opth recalled by Natures Pharmacy &
Natures Pharmacy & Compounding Center is recalling Dexamethasone (pf) 05 % opth, distributed in North Carolina. The recall was initiated on 1 Nov 2013 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-1106-2014
- FDA event ID
- 66856
- Recalling firm
- Natures Pharmacy & Compounding Center, Asheville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Nov 2013
- FDA classified
- 4 Mar 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
Timeline
| 1 Nov 2013 | Recall initiated by company | |
| 4 Mar 2014 | Classified by FDA | +123 days |
| 12 Mar 2014 | 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 Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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 (pf) 0.05 % opth.
Where it was distributed
NC
Questions about this recall
Is Dexamethasone (pf) 05 % opth recalled?
Yes. Natures Pharmacy & Compounding Center recalled Dexamethasone (pf) 05 % opth on 1 Nov 2013. The recall is Class II and its status is Terminated. Recall number D-1106-2014.
Why was it recalled?
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Which lots are affected?
All lot numbers within expiry.
Where was it sold?
NC
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.