FDA Drug Recalls

Recalls / Class III

Class IIID-0879-2022

Product

Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5

Affected lot / code info
Lot #: 100010885, Exp 11/2024

Why it was recalled

Subpotent drug: Low OOS for menthol content at the three month room temperature.

Recalling firm

Firm
Bestco LLC
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
288 Mazeppa Rd, N/A, Mooresville, North Carolina 28115-7928

Distribution

Quantity
2038 bags
Distribution pattern
CA, ID, PA, OK

Timeline

Recall initiated
2022-04-27
FDA classified
2022-05-18
Posted by FDA
2022-05-25
Terminated
2024-01-05
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0879-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.