Recalls / Class II
Class IID-0399-2019
Product
MIC B vitamin liquid 25/50/50/1/1/1mg/ml RX glass vial
- Affected lot / code info
- 1) 10192018@8 exp 2/28/19, MIC Ba w/ aminos 2) 10292018@15 exp 1/31/19, MIC B
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
- 310 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-0399-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.