Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide with the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0956-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2017
- FDA report date
- Jul 19, 2017
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0956-2017, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77595
- Address
- 9265 Kirby Dr
- Code information
- 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.
- Postal code
- 77054-2520
- Report date
- Jul 19, 2017
- Product type
- Drugs
- Recall number
- D-0956-2017
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Termination date
- Dec 6, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Jun 22, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 7, 2017