Recalls / Class II

Class IID-0956-2017

Product

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25

Affected lot / code info

Lot #: 6/7/17 1446 515-92225P BUD: 9/5/2017; 6/2/17 1100 515-92225P BUD: 8/31/2017; 5/31/17 1415 382-92225P BUD: 8/29/2017.

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Advanced Pharma Inc.

Notification channel

Press Release

Type

Voluntary: Firm initiated

Address

9265 Kirby Dr, Houston, Texas 77054-2520

Distribution

Distribution pattern

Nationwide with the United States

Timeline

Recall initiated

2017-06-22

FDA classified

2017-07-07

Posted by FDA

2017-07-19

Terminated

2017-12-06

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0956-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.