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

PharMEDium Services, LLC

Stephanie Hasan, Quality Manager, Clinical Pharmacist. 847-457-2220, Shasan@pharmedium.com

Media

Andrew Harrison, Acting Vice President of Quality Assurance, Regulatory Affairs & R&D 847-457-2271 aharrison@pharmedium.com

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
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
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 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.

  • 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-0178This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

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