D-1196-2014 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
- 730 10 x 1mL Cartons; 367 50 x 1 mL Cartons
Product Description
Pleo Not PORTABLE SIPS, 5X, 10 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-1. Pleo Not PORTABLE SIPS, 5X, 50 x 1mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2306-2.
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 1mL): Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 06120, EXP: November 2015; Batch #19023; EXP: January 2018. (50 x 1ml) Portable Sips: Batch # 07099, EXP: August 2014; Batch # 15090; EXP: August 2015; Batch # 1110, EXP: October 2015; Batch #6120; EXP: November 2015;Batch # 19023; EXP January 2018.