CLASS II Drug recall · Reported 20 May 2015 · FDA Enforcement Report
Azithromycin 100 mg Rectal Suppository recalled
Health Innovations Pharmacy is recalling Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, distributed in North Carolina. The recall was initiated on 12 Feb 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-1040-2015
- FDA event ID
- 70656
- Recalling firm
- Health Innovations Pharmacy, Southern Pines, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2015
- FDA classified
- 8 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Antibiotics
Timeline
| 12 Feb 2015 | Recall initiated by company | |
| 8 May 2015 | Classified by FDA | +85 days |
| 20 May 2015 | Published in enforcement report | +12 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 and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
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
Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Where it was distributed
NC
Questions about this recall
Is Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave recalled?
Yes. Health Innovations Pharmacy recalled Azithromycin 100 mg Rectal Suppository, Health Innov Pharmacy, 295 Pinehurst Ave on 12 Feb 2015. The recall is Class II and its status is Terminated. Recall number D-1040-2015.
Why was it recalled?
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Which lots are affected?
All lots
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.