FDA Drug Recalls

Recalls / Class II

Class IID-0792-2016

Product

Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

Affected lot / code info
Lot #: 012216, 012616, 012816, 020316, 020616;

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm
Walter's Pharmacy
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
401 N 17th St, N/A, Allentown, Pennsylvania 18104-5034

Distribution

Quantity
4 bottles
Distribution pattern
PA

Timeline

Recall initiated
2016-02-12
FDA classified
2016-03-29
Posted by FDA
2016-04-06
Terminated
2017-01-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0792-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.