Recalls / Class II
Class IID-0396-2019
Product
Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial
- Affected lot / code info
- 10252018@24
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1350 Ne Stephens St Ste 42, N/A, Roseburg, Oregon 97470-6410
Distribution
- Quantity
- 20 ml
- Distribution pattern
- Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Timeline
- Recall initiated
- 2019-01-02
- FDA classified
- 2019-01-27
- Posted by FDA
- 2019-01-09
- Terminated
- 2023-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0396-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.