FDA Drug Recalls

Recalls / Class II

Class IID-1113-2015

Product

SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist. By: Insight Pharmaceuticals, LLC, Trevose, PA 19053-8433

Affected lot / code info
Lot #: 42451, Exp 09/17

Why it was recalled

Labeling: Label Mix-Up: An incorrect book label for Sucrets Sore Throat, Cough & Dry Mouth Honey Lemon lozenges was applied to the underside of the Sucrets Sore Throat & Cough Vapor Cherry lozenges tin.

Recalling firm

Firm
Medtech Products, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
660 White Plains Rd, N/A, Tarrytown, New York 10591-5139

Distribution

Quantity
107,832 tins
Distribution pattern
Nationwide and Puerto Rico

Timeline

Recall initiated
2015-05-21
FDA classified
2015-06-01
Posted by FDA
2015-06-10
Terminated
2018-06-06
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1113-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.