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 |
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 [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
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