Recalls / Class II
Class IID-0466-2019
Product
ICB-Complex, injection,Inositol/Choline/B1/B2/B3/B5/B6/B12/Leucine/Carnitine/Chromium/Lidocaine: 25mg/25mg/5mg/2.5mg/25mg/5mg/5mg/0.1mg/1.5mg/25mg/25mg/10mg/ML, 10ml, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
- Affected lot / code info
- Lots: 09262018@1 BUD: 12/25/2018; 10232018@5 BUD: 1/21/2019; 11012018@3 BUD: 1/30/2019
Why it was recalled
Lack of sterility assurance.
Recalling firm
- Firm
- Promise Pharmacy, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31818 Us Highway 19 N, N/A, Palm Harbor, Florida 34684-3713
Distribution
- Quantity
- 846 vials
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-12-17
- FDA classified
- 2019-02-08
- Posted by FDA
- 2019-02-20
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0466-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.