Drug & medication recalls Moderate risk

American Pharmaceutical Ingredients LLC recalls Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 585…

Recall date
March 7, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0592-2018
FDA classification
Class II
Brand / firm
American Pharmaceutical Ingredients LLC
Sold / distributed
Nationwide in the USA.

Why it was recalled

Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.

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

What was recalled

Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients

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