FDA recall D-1198-2014

Terra-Medica Inc. · Class II · drug

Product

Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-2.

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-1198-2014