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Recall Observatory FDA recall evidence

Drug product

CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.

D-1419-2015

July 02, 2015

Class III

Product summary

Firm
Bestco, Inc.
Event
Event 72069
Status
Terminated
Classification
Class III
Quantity
a) 149,856 Bags; b) 19,200 Bags.
Official record key
drug-enforcement:D-1419-2015

Official wording

Reason: Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.

Code information: a) Lot #: 50122U3, Expiry: 01/2017; Lot #: 50122U1, Expiry: 01/2017; and b) Lot #: 50122U2, Expiry: 01/2017.

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Tablets