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Health product recall

SPS-1 (2016-12-18)

Starting date:
December 18, 2016
Posting date:
January 5, 2017
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Unacceptable risk to health
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-61678

Reason

Affected lots may contain microbial contamination.

Depth of distribution

Hospitals - Nova Scotia, Quebec, Alberta, British Columbia

Affected products

SPS-1 (2016-12-18)

DIN, NPN, DIN-HIM

No market authorization

Dosage form

Cold Storage Solution

Strength

Hydroxyethyl starch 50 g / 1000 mL
Lactobionic acid 35.83 g / 1000 mL
Potassium Phosphate monobasic 3.4 g / 1000 mL
Magnesium sulphate heptahydrate 1.23 g / 1000 mL
Raffinose pentahydrate 17.83 g / 1000 mL
Adenosine 1.34 g / 1000  mL
Allopurinol 0.136 g /1000 mL
Glutathione (reduced form) 0.922 g  / 1000 mL
Potassium Hydroxide 5.61 g / 1000 mL
Sodium Hydroxide / Hydrochloric Acid adjust to ph 7.4

Lot or serial number

PBR-0060-392 (1 L)
PBR-0074-330 (2 L)

Companies

Recalling Firm
Organ Recovery Systems Inc.
One Pierce Place, Suite 475W
Itasca
60143
Illinois
UNITED STATES
Marketing Authorization Holder
Not Applicable

Date modified: