Classified in: Health
Subject: RCL

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

LAKE FOREST, Ill., June 26, 2017 /PRNewswire/ -- 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
2K5281	10 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag	171280011S	8/7/2017	61553-281-11
2K5282	15 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag	171530101S	9/3/2017	61553-282-11
		171230071D	8/2/2017	61553-282-11
		171170014S	7/27/2017	61553-282-11
		171210127S	7/31/2017	61553-282-11
		171240191S	8/3/2017	61553-282-11
		171320190S	8/13/2017	61553-282-11
		171570058D	9/5/2017	61553-282-11
		171240002D	8/3/2017	61553-282-11
		171240004D	8/3/2017	61553-282-11
		171280041D	8/7/2017	61553-282-11
		171290077D	8/8/2017	61553-282-11
		171300076D	8/9/2017	61553-282-11
		171310058D	8/10/2017	61553-282-11
		171320059D	8/13/2017	61553-282-11
		171360062D	8/15/2017	61553-282-11
		171360068D	8/15/2017	61553-282-11
		171380076D	8/17/2017	61553-282-11
		171390064D	8/20/2017	61553-282-11
		171390065D	8/20/2017	61553-282-11
		171500064D	8/29/2017	61553-282-11
2K5283	30 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 500 mL in 500 mL Intravia Bag	171350099S	8/14/2017	61553-283-03
2K5284	7 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171220061D	8/1/2017	61553-284-48
		171430008D	8/22/2017	61553-284-48
		171450015D	8/24/2017	61553-284-48
		171510062D	8/30/2017	61553-284-48
		171250023D	8/6/2017	61553-284-48
2K5285	30 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 500 mL in 500 mL Intravia Bag	171240007S	8/3/2017	61553-285-03
		171280055D	8/7/2017	61553-285-03
		171370011S	8/16/2017	61553-285-03
		171360005S	8/14/2017	61553-285-03
		171320008S	8/13/2017	61553-285-03
		171380086D	8/17/2017	61553-285-03
		171500071D	8/29/2017	61553-285-03
		171280055D	8/7/2017	61553-285-03
		171320003D	8/10/2017	61553-285-03
2K5286	9 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171520062D	8/31/2017	61553-286-48
2K5287	20 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171320001D	8/10/2017	61553-287-48
2K5288	10 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171290006S	8/7/2017	61553-288-48
		171280125S	8/7/2017	61553-288-48
		171280006S	8/6/2017	61553-288-48
		171360002S	8/15/2017	61553-288-48
		171290028D	8/8/2017	61553-288-48
2K5290	30 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag	171180027S	7/29/2017	61553-290-11
		171230013S	8/2/2017	61553-290-11
		171360008S	8/14/2017	61553-290-11
		171560025D	9/4/2017	61553-290-11
		171360019D	8/15/2017	61553-290-11
		171220058D	8/1/2017	61553-290-11
		171380085D	8/17/2017	61553-290-11
		171430069D	8/22/2017	61553-290-11
2K5291	15 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag with Additive Cap	171210005S	7/30/2017	61553-291-11
		171500072D	8/29/2017	61553-291-11
		171230008D	8/2/2017	61553-291-11
		171560028D	9/4/2017	61553-291-11
2K5292	15 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 150 mL in 150 mL Intravia Bag	171370005S	8/15/2017	61553-292-01
		171450012D	8/24/2017	61553-292-01
		171510059D	8/30/2017	61553-292-01
		171440016D	8/23/2017	61553-292-01
		171280054D	8/7/2017	61553-292-01
		171560027D	9/4/2017	61553-292-01
		171320002D	8/10/2017	61553-292-01
2K5295	15 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171320006S	8/13/2017	61553-295-48
		171320014D	8/13/2017	61553-295-48
		171360020D	8/15/2017	61553-295-48
		171520063D	8/31/2017	61553-295-48
2K5298	7.5 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag	171320109S	8/13/2017	61553-298-48
		171210102S	7/31/2017	61553-298-48
		171560012S	9/4/2017	61553-298-48
2K5299	7.5 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 100 mL in 150 mL Intravia Bag	171450017D	8/24/2017	61553-299-48
2K5300	15 mMo1 Potassium Phosphate (Preservative Free) in 5% Dextrose	171420030D	8/21/2017	61553-300-11
2K5301	40 mMol Potassium Phosphate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag	171220007S	7/31/2017	61553-364-65
		171280129S	8/7/2017	61553-364-65
		171320112S	8/13/2017	61553-364-65
		171590010S	9/7/2017	61553-364-65
2K5310	9 mMol Potassium Phosphate (Preservative Free) in 5% Dextrose 50 mL in 50 mL Intravia Bag	171560007S	9/4/2017	61553-310-41
2K5310		171160002S	7/26/2017	61553-310-41
3364NO	20 mg/mL Succinylcholine Chloride Injection (Preserved) 10 mL in 10 mL BD Syringe	171450001D	8/23/2017	61553-364-65
		171450002D	8/23/2017	61553-364-65
		171450056D	8/24/2017	61553-364-65
		171440058D	8/23/2017	61553-364-65
		171390027D	8/20/2017	61553-364-65
		171390026D	8/20/2017	61553-364-65
		171430062D	8/22/2017	61553-364-65
		171420074D	8/21/2017	61553-364-65
		171370064D	8/16/2017	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 [email protected].

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.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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

Contact

Consumers

PharMEDium Services, LLC
Stephanie Hasan, Quality Manager, Clinical Pharmacist. 847-457-2220, [email protected]

SOURCE PharMEDium Services, LLC

These press releases may also interest you

at 12:48	Pendopharm signs exclusive distribution agreement with Ascendis Pharma A/S for TransContm PTH in Canada
	Pendopharm, a division of Pharmascience Inc., announced today that it has signed an exclusive distribution agreement with Ascendis Pharma A/S ("Ascendis"), a global biopharmaceutical company headquartered in Copenhagen, Denmark. Under the terms of...
at 12:36	IMPERIAL TOBACCO CANADA ADVOCATES FOR A NEW FEDERAL FRAMEWORK THAT TREATS ALL NICOTINE REPLACEMENT THERAPIES (NRTs) EQUALLY
	Imperial Tobacco Canada Limited ("ITCAN") has officially submitted its feedback to Health Canada regarding the proposed Ministerial Order on nicotine replacement therapy products (NRTs). ITCAN strongly believes that NRTs, especially innovative...
at 12:20	Global Regenerative Medicine Partnering Deals Analysis Report and Directory 2016-2024: 1771 Collaboration, Development, Research and Licensing Deals by Company A-Z, Deal Type and Therapy Area - ResearchAndMarkets.com
	The "Regenerative Medicine Collaboration and Licensing Deals 2016-2024" report has been added to ResearchAndMarkets.com's offering. Regenerative Medicine Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented...
at 12:10	Diagnostic Imaging Partnering Analysis Report and Directory 2016-2024: 628 Collaboration, Development, Research and Licensing Deals by Company A-Z, Deal Type and Therapy Area - ResearchAndMarkets.com
	The "Diagnostic Imaging Collaboration and Licensing Deals 2016-2024" report has been added to ResearchAndMarkets.com's offering. Diagnostic Imaging Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to...
at 12:05	KFSH&RC Achieves Remarkable 98% Survival Rate in 400 Robotic Cardiac Surgeries
	King Faisal Specialist Hospital & Research Centre (KFSH&RC) has achieved a significant milestone in its Robotic Cardiac Surgery Program, which was initiated in February 2019. Within its first year, the program performed 105 cardiac procedures. As of...
at 11:55	Global Infectious Vaccine Partnering Deals Analysis Report and Directory 2016-2024: Collaboration, Development, Research and Licensing Deals by Company A-Z, Deal Type and Therapy Area - ResearchAndMarkets.com
	The "Infectious Vaccine Collaboration and Licensing Deals 2016-2024" report has been added to ResearchAndMarkets.com's offering. Infectious Vaccine Collaboration and Licensing Deals provides a comprehensive understanding and unprecedented access to...
	More news about Health...

News published on 26 june 2017 at 18:46 and distributed by:

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

These press releases may also interest you

Le Lézard

Others sections

Follow us