FDA recall D-1206-2014

Product

Pleo Fort PORTABLE SIPS 5X, 10 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-1. Pleo Fort PORTABLE SIPS 5X, 50 x 1 mL Carton. Oral Homeopathic Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1105-2.

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-1206-2014