CLASS II Drug recall · Reported 29 Apr 2015 · FDA Enforcement Report
Miltefosine active pharmaceutical ingredient recalled
Attix Pharmaceuticals is recalling Miltefosine active pharmaceutical ingredient, distributed nationwide in the US. The recall was initiated on 14 Nov 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-798-2015
- FDA event ID
- 70452
- Recalling firm
- Attix Pharmaceuticals, Toronto
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Nov 2014
- FDA classified
- 20 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
Timeline
| 14 Nov 2014 | Recall initiated by company | |
| 20 Apr 2015 | Classified by FDA | +157 days |
| 29 Apr 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Miltefosine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Where it was distributed
Nationwide to compounding pharmacies and research organizations.
Stores named: Walmart
Questions about this recall
Is Miltefosine active pharmaceutical ingredient recalled?
Yes. Attix Pharmaceuticals recalled Miltefosine active pharmaceutical ingredient on 14 Nov 2014. The recall is Class II and its status is Terminated. Recall number D-798-2015.
Why was it recalled?
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Which lots are affected?
All lots repackaged and distributed between 01/05/12 to 02/12/15
Where was it sold?
Nationwide to compounding pharmacies and research organizations.
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 Attix Pharmaceuticals
All 471| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mycophenolate Mofetil, Bulk Powder, Quantity recalled | Attix Pharmaceuticals | Manufacturing (CGMP) Deviations | CO |
| Drug | CLASS II | Azithromycin Dihydrate active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Bromocriptine Mesylate active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Droperidol active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Meloxicam active pharmaceutical ingredient recalled | Attix Pharmaceuticals | Packaging Defects | Nationwide |