FDA Drug Recalls

Recalls / Class II

Class IID-0544-2016

Product

Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Affected lot / code info
All lots within expiry.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Walgreens Infusion Services
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
14220 Northbrook Dr Ste 100B, N/A, San Antonio, Texas 78232-5045

Distribution

Quantity
30 syringes
Distribution pattern
Texas

Timeline

Recall initiated
2015-11-10
FDA classified
2015-12-30
Posted by FDA
2016-01-06
Terminated
2017-10-18
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0544-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls