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Solu-Medrol 1G solvent 8mL Act-O-Vial (2013-12-23)
- Starting date:
- December 23, 2013
- Posting date:
- January 6, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37407
Recalled Products
Solu-Medrol 1G solvent 8mL Act-O-Vial
Reason
Out-of-specification result obtained for solubility test for stability lots stored at 25°C / 75 % RH and 30°C / 75 % RH. The specification for solubility of NMT 60s was exceeded. Investigation determined that Canadian marketed lot 0BSDW was impacted.
Depth of distribution
Wholesalers, hospitals, pharmacies in Canada
Affected products
Solu-Medrol 1G solvent 8mL Act-O-Vial
DIN, NPN, DIN-HIM
DIN 02063697
Dosage form
sterile powder and diluent
Strength
125 mg/mL
Lot or serial number
0BSDW
Companies
- Recalling Firm
-
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland
H9J 2M5
Quebec
CANADA
- Marketing Authorization Holder
-
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland
H9J 2M5
Quebec
CANADA