Recalls / Class II
Class IID-0954-2017
Product
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
- Affected lot / code info
- Lot #: 5/23/17 1404 299-92625P, BUD: 8/21/2017; 5/26/2017 1250 297-92625P, BUD 8/24/2017.
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
- Quantity
- 72 units
- 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-0954-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.