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One hundred twenty-four pregnant women in Canada received 12 mcg of oral vitamin B 12 once daily beginning at 13 to 22 weeks gestation and continuing through 8 weeks postpartum when blood and breastmilk were sampled for vitamin B 12 measurement

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In some cases, recovery might take longer than expected

Prevalence of vitamin B12 deficiency among exclusively breast fed term infants in South India. Journal of Tropical Pediatrics 67(1) (2021): fmaa114

After consideration of the public comment we received and our review of the application, we agree with the applicant and have determined that the SCOUT MD TM Delivery System meets the eligibility criterion at 419.66(b)(3)