Drug & medication recalls Moderate risk

Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland…

Recall date
April 15, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1252-2020
FDA classification
Class II
Brand / firm
Lupin Pharmaceuticals Inc.
Sold / distributed
Nationwide with the United States and Puerto Rico.

Why it was recalled

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

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

What was recalled

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

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