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FDAMarch 18, 2020drug

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

What to do

FDA enforcement status: Terminated

Brands named

aurobindo pharmaaurobindo

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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