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Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy

FDA Recall #D-0272-2017 — Class II — November 17, 2016

Recall #D-0272-2017 Date: November 17, 2016 Classification: Class II Status: Ongoing

Product Description

Methylcobalamin 1,000 mcg/mL, 10 mL and 30 mL. Compounded by Tri-Coast Pharmacy

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

Tri-Coast Pharmacy — Juno Beach, FL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

1,458 vials

Distribution

Nationwide

Code Information

Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05312016KK, 05262016A (11/22/2016), 060920161 (12/06/2016), 07262016B (01/22/2017), 07062016C (12/31/2016), 08292016B (02/25/2017), 10132016F (04/11/2017), 10252016K (02/28/2017), 07262016C (01/22/2017), 09152016 (02/28/2017)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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