Why it was recalled
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Product description
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
Lot numbers, UPCs & expiration codes
Lot # 660621A, Exp 01/31/18
Where it was sold
US Nationwide.
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-0008-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 3, 2016
- FDA report date
- Oct 12, 2016
- Quantity
- 15,109 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceutical
Original FDA data
Every field from FDA enforcement report D-0008-2017, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 75260
- Address
- 1809 Wilson Rd
- Code information
- Lot # 660621A, Exp 01/31/18
- Postal code
- 43228-9579
- Report date
- Oct 12, 2016
- Product type
- Drugs
- Recall number
- D-0008-2017
- Classification
- Class II
- Recalling firm
- West-Ward Pharmaceutical
- Product quantity
- 15,109 bottles
- Termination date
- Dec 18, 2017
- Reason for recall
- Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Oct 3, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 6, 2016