D-1204-2014 Class II Terminated
FDA drug recall D-1204-2014 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: 2147 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
- 2147 cartons
Product Description
Pleo Fort SUPPOSITORIES 3X, 10 Suppository Carton, Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1106-1.
Reason for Recall
Penicillin Cross Contamination
Distribution Pattern
Products were distributed US Nationwide, to Canada, to Philippines, and through internet sales.
Code Information
Batch # 3110; EXP: October 2015; Batch # 1112; EXP: October 2017.