Drug product
Pleo Not PORTABLE SIPS, 6X, 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: 49807-2308-1. Pleo Not PORTABLE SIPS, 6X, 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: 49807-2308-2 .
D-1197-2014
Product summary
- Event
- Event 67723
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 10 x 1 mL Cartons; 51 50 x 1 mL Cartons
- Official record key
drug-enforcement:D-1197-2014
Official wording
Reason: Penicillin Cross Contamination
Code information: (10 x 1mL) Batch # 25050, EXP: April 2015. (50 x 1mL): Batch # 25050, EXP: April 2015.
Distribution pattern: Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Derived failure modes
-
Unknown
Penicillin Cross Contamination