CLASS II Drug recall · Reported 8 Oct 2014 · FDA Enforcement Report
All sterile drugs compounded between 2/21/14 and 2/24/14 recalled
New England Home Therapies is recalling All sterile drugs compounded between 2/21/14 and 2/24/14. The recall was initiated on 26 Feb 2014 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-0003-2015
- FDA event ID
- 67687
- Recalling firm
- New England Home Therapies, Southborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2014
- FDA classified
- 1 Oct 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 26 Feb 2014 | Recall initiated by company | |
| 1 Oct 2014 | Classified by FDA | +217 days |
| 8 Oct 2014 | 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
Lack of Assurance of Sterility: All compounded products.
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
All sterile drugs compounded between 2/21/14 and 2/24/14.
Where it was distributed
US: New England
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: All compounded products.
Which lots are affected?
Expiration dates between 3/5/14 and 3/10/14.
Where was it sold?
US: New England
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.