D-0856-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 25, 2016
- Initiation Date
- February 29, 2016
- Termination Date
- June 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 9816 bottles; b) 9648 bottles
Product Description
col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
Reason for Recall
Superpotent Drug: High out of specification results for assay at the 6 month time point interval.
Distribution Pattern
Nationwide
Code Information
Lot #: 5C344105, Exp 02/17