Drug & medication recalls Moderate risk

HCG/METHYLCOBALAMIN/FOLIC ACID recalled over sterility concerns

Recall date
May 17, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Well Care Compounding Pharmacy recalls HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las…
Recall number
D-0990-2016
FDA classification
Class II
Brand / firm
Well Care Compounding Pharmacy
Sold / distributed
NV

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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