FDA recall D-1430-2019

Product

Diphenhydramine HCL Liquid, 12.5 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0123-03.

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-1430-2019