FDA recall D-1005-2020

H J Harkins Company Inc dba Pharma Pac · Class II · drug

Product

Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433

Reason for recall

Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2020-03-06
Report date: 2020-03-18
Termination date: 2024-01-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grover Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1005-2020