CLASS II Drug recall · Reported 22 Oct 2014 · FDA Enforcement Report
Hydroxyprogesterone Caproate 250 MG/ML (in Sesame Oil) recalled
Avella of Deer Valley is recalling Hydroxyprogesterone Caproate 250 MG/ML (in Sesame Oil), distributed nationwide in the US. The recall was initiated on 1 Oct 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-0016-2014
- FDA event ID
- 69405
- Recalling firm
- Avella of Deer Valley, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2014
- FDA classified
- 10 Oct 2014
- Reported
- 22 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Oct 2014 | Recall initiated by company | |
| 10 Oct 2014 | Classified by FDA | +9 days |
| 22 Oct 2014 | 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
Crystallization: Formation of crystals observed in product.
Product as listed by the FDA
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Crystallization: Formation of crystals observed in product.
Which lots are affected?
Lot# 12-20140207@109; Exp. 12/14 Lot# 12-20142107@82; Exp. 01/15
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 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.
More recalls from Avella of Deer Valley
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bevacizumab 1.25 mg/ PF, Avella Specialty Pharmacy, Phoenix recalled | Avella of Deer Valley | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin PF (BSS) 1%, Avella Specialty Pharmacy, Phoenix recalled | Avella of Deer Valley | Sterility | Nationwide |
Other Hydroxyprogesterone Caproate recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxyprogesterone Caproate Injection recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection vial recalled | First Pharma Associates | Sterility | ID, WA |
| Drug | CLASS II | Hydroxyprogesterone Caproate 250 MG/ML Oil* Injectable, (a) recalled | Health Solutions Pharmacy Center | Sterility | OR |
| Drug | CLASS II | Hydroxyprogesterone Caproate, 250 mg per mL vial, Rx recalled | Vann Healthcare Services | Sterility | KY |
| Drug | CLASS II | Hydroxyprogesterone Caproate 250mg/ml recalled by RX South | RX South | Temperature Abuse | MD, VA |