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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