Why it was recalled
Lack of Assurance of Sterility; media fill failure at manufacturer
Product description
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
Lot numbers, UPCs & expiration codes
Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017
Where it was sold
Nationwide
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-0991-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2017
- FDA report date
- Jul 26, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMedium Services, Llc
Original FDA data
Every field from FDA enforcement report D-0991-2017, exactly as published.
Show all FDA fields
- City
- Sugar Land
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 77634
- Address
- 12620 W Airport Blvd Ste 130
- Code information
- Lots: 171220061D Exp. 8/1/2017, 171250023D Exp. 8/6/2017, 171430008D Exp. 8/22/2017, 171450015D Exp. 8/24/2017, 171510062D Exp. 8/30/2017
- Postal code
- 77478-6200
- Report date
- Jul 26, 2017
- Product type
- Drugs
- Recall number
- D-0991-2017
- Classification
- Class II
- Recalling firm
- PharMedium Services, Llc
- Termination date
- Apr 29, 2020
- Reason for recall
- Lack of Assurance of Sterility; media fill failure at manufacturer
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5284 NDC# 61553-284-48
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 26, 2017
- Initial firm notification
- Press Release
- Center classification date
- Jul 14, 2017