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Equate Ferrous Sulfate Compliments Ferrous Sulfate Overwaitea Ferrous Sulfate Truly Ferrous Sulfate

Starting date:
March 23, 2010
Posting date:
April 26, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
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 R2J 3W2
Marketing Authorization Holder
Vita Health Products Inc. 150 Beghin Avenue Winnipeg, Manitoba R2J 3W2