DrugApr 22, 2020
H J Harkins Company Inc dba Pharma Pac Acetaminophen and Codeine Phosphate 300/30 mg tablet recall — FDA D-1246-2020
cGMP Deviations
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
Recall history in this database
Classification mix: Class II: 4.
DrugMar 18, 2020
H J Harkins Company Inc dba Pharma Pac Acetaminophen 500 mg tablet recall — FDA D-1005-2020
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…
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
DrugJan 29, 2020
H J Harkins Company Inc dba Pharma Pac Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count recall — FDA D-0793-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
DrugAug 7, 2019
H J Harkins Company Inc dba Pharma Pac Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / recall — FDA D-1580-2019
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Class IIFDA: TerminatedH J Harkins Company Inc dba Pharma Pac
Understanding this recall history
This page summarizes recall records in which the official source identifies H J Harkins Company Inc dba Pharma Pac as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.