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Recall Observatory FDA recall evidence

Drug product

CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Flavor 20 Single-Use 0.08 fl. oz. (2.5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 050428597958

D-1302-2019

May 02, 2019

Class II

Product summary

Firm
Unipharma, Llc.
Event
Event 82754
Status
Terminated
Classification
Class II
Quantity
38640 cartons
Official record key
drug-enforcement:D-1302-2019

Official wording

Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

Code information: Lots: 80043 Exp. 07/05/20; 80047 Exp. 07/31/20

Distribution pattern: Nationwide and Venezuela

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations