Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.
Equate Ferrous Sulfate Compliments Ferrous Sulfate Overwaitea Ferrous Sulfate Truly Ferrous Sulfate (March 23, 2010)
- Starting date:
- March 23, 2010
- Posting date:
- April 26, 2010
- Type of communication:
- Drug Recall
- Subcategory:
- Natural health products
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-2010A125
Reason
A Stability Lot failed USP dissolution requirements at 24 months (not less than 75% (Q) dissolved in 45 minutes). Further investigation revealed two additional stability lots failed dissolution at 27 and 29 months.
Depth of distribution
Retail Distribution in Canada. No Export.
Affected products
Equate Ferrous Sulfate, Compliments Ferrous Sulfate, Overwaitea Ferrous Sulfate , Truly Ferrous Sulfate
DIN, NPN, DIN-HIM
NPN 00782114
Dosage form
Tablet
Strength
- 300 mg
Lot or serial number
Equate/ Ferrous Sulfate - Lot Numbers: 6H13612K1,6I01212K6; 6I1281433; 6I12814PX, 6I0121433, 7K1411R7G; 7K1411KEG, 7A03717XG; 7A037162W, 7C10117XG; 7C10119P2; 7C09119P2, 7G0151CC6; 7G0151BNT, 7J0591CWQ; 7J0701JE1, 7L0541KEG; 7L0541R7G,8J0121UPP; 8J0121RAT; 8J0121WGL; 8J0121U1N Compliments/ Ferrous Sulfate - Lot Numbers: 6I01212K4; 6I1281432; 6I12814JC, 7L0541SZ2, 7A037162V, 7C0911858; 7C1011AK1, 7J0591CWR; 7J0591F0N; 7J0701F0N, 7K1411L93, 8J0121VMZ; 8J0121RV2; 8J0121SE0, 9L0691ZJ8 Overwaitea/ Ferrous Sulfate - Lot Numbers: 6I01212K7; 6I1281430, 7K1411K0K; 7L0541MVU; 7L0541SZ1, 7A037162Y, 7C09118WM; 7C0911857; 7C10118WM, 7G0151BZ9, 7J0591CWS; 7J0701HQU; 7J0701F0P, 8J0121PJB, 8J0121RAQ, 8J0121VMY Truly /Ferrous Sulfate - Lot Numbers: 6I01212K5; 6I1281431,7K1411JYM; 7K1411JYB, 7A037162X, 7C10117XF; 7C09117XF; 7C1011AK0, 7G0151C39, 7J0591F0M; 7J0701GM3, 7L0541SZ3, 8J0121VMX
Companies
- Recalling Firm
- Vita Health Products Inc.
150 Beghin Avenue
Winnipeg Manitoba
Canada R2J 3W2
- Marketing Authorization Holder
- Vita Health Products Inc.
150 Beghin Avenue
Winnipeg Manitoba
Canada R2J 3W2
- Date modified: