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HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care C...

FDA Recall #D-0990-2016 — Class II — May 17, 2016

Recall #D-0990-2016 Date: May 17, 2016 Classification: Class II Status: Terminated

Product Description

HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

Reason for Recall

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Recalling Firm

Well Care Compounding Pharmacy — Las Vegas, NV

Classification

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

Product Type

Drugs

Product Quantity

869 Units (Total All Products)

Distribution

NV

Code Information

Lot #: 03012016:82@33, Exp. 05/30/2016; Lot #: 03012016:65@41, Exp. 06/16/2016; Lot #: 04142016:89@48, Exp. 07/12/2016; Lot #: 04142016: 28@49, Exp. 07/17/2016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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