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pms-Amantadine HCL (2016-05-11)
- Starting date:
- May 11, 2016
- Posting date:
- May 26, 2016
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58478
Reason
The recall is due to an out-of-specification result for a dissolution test.
Depth of distribution
Wholesalers and pharmacies (direct or via wholesalers) in Canada
Affected products
pms-Amantadine HCL
DIN, NPN, DIN-HIM
DIN 01990403Dosage form
Capsule
Strength
100 mg
Lot or serial number
492504
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montreal
H4P 2T4
Quebec
CANADA