Drug & medication recalls Moderate risk

Pharmedium Services, LLC recalls labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product co…

Recall date
July 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0058-2017
FDA classification
Class II
Brand / firm
Pharmedium Services, LLC
Sold / distributed
Nationwide

Why it was recalled

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

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

What was recalled

labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.

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