FDA Drug Recalls

Recalls / Class II

Class IID-1569-2019

Product

Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

Affected lot / code info
Lots #: 5506N, Exp 9/21/2019; 7180N, Exp 12/29/2019

Why it was recalled

Lack of Processing Controls

Recalling firm

Firm
Wise Pharmacy
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
6179 S Balsam Way Ste 150, N/A, Littleton, Colorado 80123-3095

Distribution

Quantity
27 vials
Distribution pattern
CO, TX, WY

Timeline

Recall initiated
2019-07-22
FDA classified
2019-07-31
Posted by FDA
2019-08-07
Terminated
2020-02-03
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1569-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.