Status
Terminated
Drug Enforcement D-149-2013
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Classification
Class II
Report Date
February 13, 2013
Termination Date
March 18, 2015
Product Information
- Product description
- PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
- Product quantity
- 128,319 bottles
- Reason for recall
- Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-149-2013
- Event ID
- 63969
- Recall initiation date
- December 5, 2012
- Center classification date
- February 5, 2013
- Code info
- Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
- More code info
- —