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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