Recalls / Class II
Class IID-149-2013
Product
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.
- Affected lot / code info
- Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Why it was recalled
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 128,319 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-12-05
- FDA classified
- 2013-02-05
- Posted by FDA
- 2013-02-13
- Terminated
- 2015-03-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-149-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.