FDA recall D-1429-2019

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

Product

Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04

Reason for recall

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

Distribution

Nationwide Within the United States

Key facts

Status: Terminated
Initiation date: 2019-06-24
Report date: 2019-07-03
Termination date: 2023-05-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grover Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1429-2019