D-1211-2014 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
111 10 x 1 mls; 39 50 x 1 mls

Product Description

Pleo Ex PORTABLE SIPS 5X, 10 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-1. PLEO--EX Portable Sips 5X, 50 x 1 mL, Oral Homeopathic Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp. 1465 Slator Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, NDC: 49807-1005-2.

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: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017. 50 x 1 mL: Batch # 09020; EXP: January 2015; Batch # 03052, EXP: April 2017.