FDA recall D-1360-2019

Torrent Pharma Inc · Class II · drug

Product

Hyoscyamine Sulfate Elixir 0.125 mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC:39328-048-16, Patrin Pharma, Skokie IL 60076.

Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Distribution

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

Key facts

Status
Terminated
Initiation date
2019-05-21
Report date
2019-06-19
Termination date
2020-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Levittown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1360-2019