H J Harkins Company Inc dba Pharma Pac Recalls

All product recalls associated with H J Harkins Company Inc dba Pharma Pac.

Get alerts for this brand

Recall Summary

Total Recalls

9

Past Year

0

Class I (Serious)

0

Most Recent

Apr 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Acetaminophen Codeine Tablet (Pharma Pac) – Quality Deviation (2020)

cGMP Deviations

Class IIModerate

FDAApr 15, 2020AZ, CA, IN• H J Harkins Company Inc dba Pharma Pac

Acetaminophen 500mg (Pharma Pac) – Foreign Tablet Mixup (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 bottle

Class IIModerate

FDAMar 6, 2020Nationwide• H J Harkins Company Inc dba Pharma Pac

Ranitidine Tablets (Pharma Pac) – NDMA Contamination (2020)

CGMP Deviations: Presence of NDMA impurity detected in product.

Class II

Moderate

FDAJan 6, 2020CA, FL, IN +2 more• H J Harkins Company Inc dba Pharma Pac

Neomycin Ophthalmic Solution (Pharma Pac) – Quality Control Failure (2019)

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Class IIModerate

FDAJul 12, 2019CA, IN• H J Harkins Company Inc dba Pharma Pac

Acetaminophen Children's Liquid (Pharma Pac) – microbial contamination (2019)

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAJun 24, 2019Nationwide• H J Harkins Company Inc dba Pharma Pac

Diphenhydramine HCL Liquid (Pharma Pac) – microbial contamination (2019)

Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAJun 24, 2019Nationwide• H J Harkins Company Inc dba Pharma Pac