CLASS II Drug recall · Reported 12 Feb 2014 · FDA Enforcement Report
The firm is all lots of sterile products compounded recalled
Apothecure is recalling The firm is all lots of sterile products compounded by the pharmacy that are within expiry, distributed nationwide in the US. The recall was initiated on 15 Apr 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-1066-2014
- FDA event ID
- 64921
- Recalling firm
- Apothecure, Dallas, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2013
- FDA classified
- 4 Feb 2014
- Reported
- 12 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 15 Apr 2013 | Recall initiated by company | |
| 4 Feb 2014 | Classified by FDA | +295 days |
| 12 Feb 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 Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an 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
The firm is recalling all lots of sterile products compounded by the pharmacy that are within expiry.
Where it was distributed
Nationwide
Questions about this recall
Is The firm is all lots of sterile products compounded by the pharmacy that are within expiry recalled?
Yes. Apothecure recalled The firm is all lots of sterile products compounded by the pharmacy that are within expiry on 15 Apr 2013. The recall is Class II and its status is Terminated. Recall number D-1066-2014.
Why was it recalled?
Lack of Assurance of Sterility: The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes identified during an FDA inspection.
Which lots are affected?
All Lots
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.