Why it was recalled
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
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.
Lot numbers, UPCs & expiration codes
Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-149-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 5, 2012
- FDA report date
- Feb 13, 2013
- Quantity
- 128,319 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-ward Pharmaceutical Corp.
Original FDA data
Every field from FDA enforcement report D-149-2013, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 63969
- Address
- 465 Industrial Way W
- Code information
- Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15
- Postal code
- 07724-2209
- Report date
- Feb 13, 2013
- Product type
- Drugs
- Recall number
- D-149-2013
- Classification
- Class II
- Recalling firm
- West-ward Pharmaceutical Corp.
- Product quantity
- 128,319 bottles
- Termination date
- Mar 18, 2015
- Reason for recall
- Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Dec 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Feb 5, 2013