Drug 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.
D-1206-2014
Product summary
- Event
- Event 67723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 126 10 x 1 ml Cartons; 76 50 x 1ml Cartons
- Official record key
drug-enforcement:D-1206-2014
Official wording
Reason: Penicillin Cross Contamination.
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.
Distribution pattern: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Derived failure modes
-
Unknown
Penicillin Cross Contamination.