FDA Drug Recalls

Recalls / Class II

Class IID-0195-2024

Product

Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10

Brand name
Natural Cherry Honey Herb Throat Drops
Generic name
Menthol
Active ingredient
Menthol
Route
Oral
NDC
54305-507
FDA application
M022
Affected lot / code info
Batch 2000058693

Why it was recalled

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Recalling firm

Firm
CARDINAL HEALTHCARE
Manufacturer
Ricola Ag
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7200 Cardinal Pl W, Dublin, Ohio 43017-1094

Distribution

Quantity
2 units
Distribution pattern
Nationwide USA

Timeline

Recall initiated
2022-01-26
FDA classified
2023-12-26
Posted by FDA
2024-01-03
Terminated
2024-09-29
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0195-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.