FDA recall D-1207-2014

Terra-Medica Inc. · Class II · drug

Product

Pleo-Fort DROPS 5X, 10ml bottle, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1101-1.

Reason for recall

Penicillin Cross Contamination

Distribution

Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.

Key facts

Status
Terminated
Initiation date
2014-03-03
Report date
2014-04-16
Termination date
2014-07-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ferndale, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1207-2014