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Apo-Lansoprazole SR Cap (April 13, 2010)
- Starting date:
- April 13, 2010
- Posting date:
- May 24, 2010
- 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-2010A148
Reason
Stability data shows that an unknown impurity (RRT 1.27) will exceed specifications at 12 months. According to the data analysed, RRT 1.27 is right at the limit at 9 months, and failures should be expected afterwards.
Depth of distribution
Across Canada to retail level, no export.
Affected products
Apo-Lansoprazole SR Cap
DIN, NPN, DIN-HIM
DIN 02293838
Dosage form
Capsules
Strength
- 30 mg
Lot or serial number
JF7506, JF8852, JL1444, JK2970, JK6089, JK2968, JK6096, JL1445, JD1982, JD1981, JF8268, JF8269, JF8271, JF8272, JF8273, JH5255, JG2571, JH5256, JK4983, JF8270, JG2570, JJ9671, JK2966, JK2967, JK2969, JK6087
Companies
- Recalling Firm
- Apotex Inc
50 Steinway Blvd.
Etobicoke Ontario
Canada M9W 6Y3
- Marketing Authorization Holder
- Apotex Inc
50 Steinway Blvd.
Etobicoke Ontario
Canada M9W 6Y3
- Date modified: