D-1206-2014 Class II Terminated
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.