D-0098-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- August 6, 2018
- Termination Date
- February 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,225 bottles
Product Description
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
Reason for Recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Distribution Pattern
Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
Code Information
Lot #: 1237868A, 1248900A, Exp 5/2020