Recalls / Class II
Class IID-0016-2018
Product
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride, Rx Only, Banner Health Compounding Pharmacy 7300 W Detroit St Chandler, AZ 85226, NDC 7025024801
- Affected lot / code info
- Lot #: 072717S1, Exp 10/25/2017; 080217S1, 10/31/2017; 081517S2, Exp 11/13/2017; 082917S1, Exp 11/27/2017.
Why it was recalled
Lack of Assurance of Sterility.
Recalling firm
- Firm
- Banner Pharmacy Services, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7300 W Detroit St, N/A, Chandler, Arizona 85226-2410
Distribution
- Quantity
- 972 syringes
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2017-10-10
- FDA classified
- 2017-10-23
- Posted by FDA
- 2017-11-01
- Terminated
- 2018-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0016-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.