D-1199-2014 Class II Terminated
FDA drug recall D-1199-2014 was initiated by Terra-Medica Inc. on March 3, 2014 and is designated Class II. Reason for recall: Penicillin Cross Contamination The recall status is terminated (terminated July 30, 2014). Affected quantity: 6120 cartons.
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
- 6120 cartons
Product Description
Pleo Nota- Quent DROPS 5X, 10 mL Bottles, Homeopathic Medicine, OTC Only. Made in Germany, Manufactured by: Sanum-Kehlbeck GmbH & Co. KG, Hoya, Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. NDC: 49807-0031-1.
Reason for Recall
Penicillin Cross Contamination
Distribution Pattern
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Code Information
Batch #04062 , EXP: May 2017; Batch #06062 , EXP: May 2017.