Drug Enforcement D-0332-2024

CGMP Deviations: Potential Glass and Silicone particulates in product

Status

Completed

Classification

Class II

Report Date

February 28, 2024

Termination Date

Product Information

Product description
Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115
Product quantity
a) 1597 cases/ 12 pack each b) 73 cases/4 pack each
Reason for recall
CGMP Deviations: Potential Glass and Silicone particulates in product
Recall initiation reason
Initial firm notification
E-Mail
Distribution pattern
Nationwide in the US

Location & Firm

Recalling firm
Bestco LLC
Address
288 Mazeppa Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0332-2024
Event ID
93869
Recall initiation date
January 19, 2024
Center classification date
February 16, 2024
Code info
a) 100041954, Exp 12/31/2026; b) 100042048, 100042060, Exp 12/31/2026
More code info