Drug & medication recalls Moderate risk

Colonia Care Pharmacy product recalled over sterility concerns

Recall date
July 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Colonia Care Pharmacy recalls C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Col…
Recall number
D-0016-2020
FDA classification
Class II
Brand / firm
Colonia Care Pharmacy
Sold / distributed
Patient Specific Prescriptions in NJ

Why it was recalled

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

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

What was recalled

C-MB12/HB12 5MG/5MG/ML INJ SOLN, 0.9 mL in a 3 mL syringe, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067

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