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Recall Observatory FDA recall evidence

Drug product

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

D-1229-2020

March 18, 2020

Class II

Product summary

Firm
Aurobindo Pharma USA Inc.
Event
Event 85183
Status
Terminated
Classification
Class II
Quantity
14194 units
Official record key
drug-enforcement:D-1229-2020

Official wording

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

Code information: Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations