Safety

Company Announcement

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance

For Immediate Release

June 26, 2017

Contact

Consumers

Stephanie Hasan
Shasan@pharmedium.com
847-457-2220

Media

Andrew Harrison
aharrison@pharmedium.com
847-457-2271

Announcement

PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall: https://www.fda.gov/Safety/Recalls/ucm563383.htm.

Per Hospira, in the event that impacted product is administered to a patient, there is a reasonable probability that the patient may experience adverse events ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated.

To date, PharMEDium Services has not received any reports of product complaints and/or adverse events related to the products.

These products were not distributed directly to patients or consumers, but rather to healthcare facilities (e.g. hospitals) in the United States.

The recalled lots are as follows:

Product

Strength

Lot Number

Expiration Date

NDC Number

2K528110 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag171280011S8/7/201761553-281-11
2K528215 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag171530101S
171230071D
171170014S
171210127S
171240191S
171320190S
171570058D
171240002D
171240004D
171280041D
171290077D
171300076D
171310058D
171320059D
171360062D
171360068D
171380076D
171390064D
171390065D
171500064D
9/3/2017
8/2/2017
7/27/2017
7/31/2017
8/3/2017
8/13/2017
9/5/2017
8/3/2017
8/3/2017
8/7/2017
8/8/2017
8/9/2017
8/10/2017
8/13/2017
8/15/2017
8/15/2017
8/17/2017
8/20/2017
8/20/2017
8/29/2017
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
61553-282-11
2K528330 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 500 mL in 500 mL Intravia Bag171350099S8/14/201761553-283-03
2K52847 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171220061D
171430008D
171450015D
171510062D
171250023D
8/1/2017
8/22/2017
8/24/2017
8/30/2017
8/6/2017
61553-284-48
61553-284-48
61553-284-48
61553-284-48
61553-284-48
2K528530 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 500 mL in 500 mL Intravia Bag171240007S
171280055D
171370011S
171360005S
171320008S
171380086D
171500071D
171280055D
171320003D
8/3/2017
8/7/2017
8/16/2017
8/14/2017
8/13/2017
8/17/2017
8/29/2017
8/7/2017
8/10/2017
61553-285-03
61553-285-03
61553-285-03
61553-285-03
61553-285-03
61553-285-03
61553-285-03
61553-285-03
61553-285-03
2K52869 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171520062D8/31/201761553-286-48
2K528720 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171320001D8/10/201761553-287-48
2K528810 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171290006S
171280125S
171280006S
171360002S
171290028D
8/7/2017
8/7/2017
8/6/2017
8/15/2017
8/8/2017
61553-288-48
61553-288-48
61553-288-48
61553-288-48
61553-288-48
2K529030 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag171180027S
171230013S
171360008S
171560025D
171360019D
171220058D
171380085D
171430069D
7/29/2017
8/2/2017
8/14/2017
9/4/2017
8/15/2017
8/1/2017
8/17/2017
8/22/2017
61553-290-11
61553-290-11
61553-290-11
61553-290-11
61553-290-11
61553-290-11
61553-290-11
61553-290-11
2K529115 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag with Additive Cap171210005S
171500072D
171230008D
171560028D
7/30/2017
8/29/2017
8/2/2017
9/4/2017
61553-291-11
61553-291-11
61553-291-11
61553-291-11
2K529215 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 150 mL in 150 mL Intravia Bag171370005S
171450012D
171510059D
171440016D
171280054D
171560027D
171320002D
8/15/2017
8/24/2017
8/30/2017
8/23/2017
8/7/2017
9/4/2017
8/10/2017
61553-292-01
61553-292-01
61553-292-01
61553-292-01
61553-292-01
61553-292-01
61553-292-01
2K529515 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171320006S
171320014D
171360020D
171520063D
8/13/2017
8/13/2017
8/15/2017
8/31/2017
61553-295-48
61553-295-48
61553-295-48
61553-295-48
2K52987.5 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag171320109S
171210102S
171560012S
8/13/2017
7/31/2017
9/4/2017
61553-298-48
61553-298-48
61553-298-48
2K52997.5 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 100 mL in 150 mL Intravia Bag171450017D8/24/201761553-299-48
2K530015 mMo1 Potassium Phosphate (Preservative Free) in 5% Dextrose171420030D8/21/201761553-300-11
2K530140 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag171220007S
171280129S
171320112S
171590010S
7/31/2017
8/7/2017
8/13/2017
9/7/2017
61553-364-65
61553-364-65
61553-364-65
61553-364-65
2K53109 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 50 mL in 50 mL Intravia Bag171560007S
171160002S
9/4/2017
7/26/2017
61553-310-41
61553-310-41
3364NO20 mg/mL Succinylcholine Chloride Injection (Preserved) 10 mL in 10 mL BD Syringe171450001D
171450002D
171450056D
171440058D
171390027D
171390026D
171430062D
171420074D
171370064D
8/23/2017
8/23/2017
8/24/2017
8/23/2017
8/20/2017
8/20/2017
8/22/2017
8/21/2017
8/16/2017
61553-364-65
61553-364-65
61553-364-65
61553-364-65
61553-364-65
61553-364-65
61553-364-65
61553-364-65
61553-364-65

PharMEDium Services is committed to product quality and patient safety in all instances and is therefore issuing this recall.

PharMEDium Services is notifying customers of the voluntary recall by phone. Customers that have any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy per their hospital protocol. Customers with any of the affected medications can also reference PharMEDium Services website for more information on the specific lot numbers affected and contact information: www.pharmedium.com.

Patients and healthcare providers with questions regarding this recall can contact PharMEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at shasan@pharmedium.com.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

###

Product Photos

Label - Potassium PHOSphate in 0.9% Sodium Chloride 10 mMol 250 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 15 mMol 250 mL Bag

Label - Potassium PHOSphate in 5% Dextrose 30 mMol 500 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 7 mMol in 100 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 9 mMol in 100 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 20 mMol in 100 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 10 mMol in 100 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 30 mMol in 250 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 15 mMol in 250 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 15 mMol in 150 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 15 mMol in 100 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 7.5 mMol in 100 mL Bag

Label - Potassium PHOSphate in 5% Dextrose 7.5 mMol in 100 mL Bag

Label - Potassium PHOSphate in 5% Dextrose 15 mMol in 250 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 40 mMol in 250 mL Bag

Label - Potassium PHOSphate in 5% Dextrose 9 mMol in 50 mL Bag

Label - Potassium PHOSphate in 0.9% Sodium Chloride 30 mMol in 500 mL Bag

Label – succinylcholine 20 mg per mL 200 mg per 10 mL

Page Last Updated: 06/27/2017
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