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pms-Omeprazole (2016-09-06)
- Starting date:
- September 6, 2016
- Posting date:
- September 20, 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-60306
Affected Product
pms-Omeprazole
Reason
Stability out-of-specification results for dissolution in acid stage
Depth of distribution
Wholesalers and pharmacies in Canada
Affected products
pms-Omeprazole
DIN, NPN, DIN-HIM
DIN 02310260
Dosage form
Tablet (Delayed-Release)
Strength
20 mg
Lot or serial number
- 487537B
- 491987A
- 494040A
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