D-1206-2014 Class II Terminated

Recalled by Terra-Medica Inc. — Ferndale, WA

Recall Details

Product Type
Drugs
Report Date
April 16, 2014
Initiation Date
March 3, 2014
Termination Date
July 30, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
126 10 x 1 ml Cartons; 76 50 x 1ml Cartons

Product Description

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 Pattern

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

Code Information

10 x 1 ml Cartons: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017. 50 x 1 ml: Batch # 15030; EXP: February 2015; Batch # 12122; EXP: November 2017.