Drug product
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.
D-1211-2014
Product summary
- Event
- Event 67723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111 10 x 1 mls; 39 50 x 1 mls
- Official record key
drug-enforcement:D-1211-2014
Official wording
Reason: Penicillin Cross Contamination
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.
Distribution pattern: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Derived failure modes
-
Unknown
Penicillin Cross Contamination