Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lots: a) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b) 171280054D Exp. 8/7/2017, 171320002D Exp. 8/10/2017, 171370005S Exp. 8/15/2017, 171440016D Exp. 8/23/2017, 171450012D Exp. 8/24/2017, 171510059D Exp. 8/30/2017, 171560027D Exp. 9/4/2017; c) 171170014S Exp. 7/27/2017, 171210127S Exp. 7/31/2017, 171230071D Exp. 8/2/2017, 171240002D Exp. 8/3/2017, 171240004D Exp. 8/3/2017, 171240191S Exp. 8/3/2017, 171280041D Exp. 8/7/2017, 171290077D Exp. 8/8/2017, 171300076D Exp. 8/9/2017, 171310058D Exp. 8/10/2017, 171320059D Exp. 8/13/2017, 171320190S Exp. 8/13/2017, 171360062D Exp. 8/15/2017, 171360068D Exp. 8/15/2017, 171380076D Exp. 8/17/2017, 171390064D Exp. 8/20/2017, 171390065D Exp. 8/20/2017, 171500064D Exp. 8/29/2017, 171530101S Exp. 9/3/2017, 171570058D Exp. 9/5/2017; d) 171210005S Exp. 7/30/2017, 171230008D Exp. 8/2/2017, 171500072D Exp. 8/29/2017, 171560028D Exp. 9/4/2017
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
PharMedium Services, Llc
Reason for Recall:
Lack of Assurance of Sterility; media fill failure at manufacturer
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in 150 mL Intravia Bag Service Code 2K5295 NDC# 61553-295-48; b) 150 mL in 150 mL Intravia Bag Service Code 2K5292 NDC# 61553-292-01; c) 250 mL in 250 mL Intravia Bag Service Code 2K5282 NDC# 61553-282-11; d) 250 mL in 250 mL Intravia Bag with Additive Cap Service Code 2K5291 NDC# 61553-291-11, Rx Only PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749

Product Codes/Lot Numbers:

Lots: a) 171320006S Exp. 8/13/2017, 171320014D Exp. 8/13/2017,171360020D Exp. 8/15/2017, 171520063D Exp. 8/31/2017; b) 171280054D Exp. 8/7/2017, 171320002D Exp. 8/10/2017, 171370005S Exp. 8/15/2017, 171440016D Exp. 8/23/2017, 171450012D Exp. 8/24/2017, 171510059D Exp. 8/30/2017, 171560027D Exp. 9/4/2017; c) 171170014S Exp. 7/27/2017, 171210127S Exp. 7/31/2017, 171230071D Exp. 8/2/2017, 171240002D Exp. 8/3/2017, 171240004D Exp. 8/3/2017, 171240191S Exp. 8/3/2017, 171280041D Exp. 8/7/2017, 171290077D Exp. 8/8/2017, 171300076D Exp. 8/9/2017, 171310058D Exp. 8/10/2017, 171320059D Exp. 8/13/2017, 171320190S Exp. 8/13/2017, 171360062D Exp. 8/15/2017, 171360068D Exp. 8/15/2017, 171380076D Exp. 8/17/2017, 171390064D Exp. 8/20/2017, 171390065D Exp. 8/20/2017, 171500064D Exp. 8/29/2017, 171530101S Exp. 9/3/2017, 171570058D Exp. 9/5/2017; d) 171210005S Exp. 7/30/2017, 171230008D Exp. 8/2/2017, 171500072D Exp. 8/29/2017, 171560028D Exp. 9/4/2017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0987-2017

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