Class II · ModerateRecall completed
PredniSONE Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Where it was soldNationwide and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byWest-ward Pharmaceutical Corp., Eatowntown, NJ 07724
| Distributed by / for | West-ward Pharmaceutical Corp. |
| NDC | 0143-1473-01 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | West-ward Pharmaceutical Corp. |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 128,319 bottles |
| Recall initiated | 2012-12-05 |
| Report date | 2013-02-13 |
| Recall completed | 2015-03-18 |
| Recall number | D-149-2013 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Eatontown NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.