PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- West-ward Pharmaceutical Corp.
- Reason for Recall:
- Presence of Foreign Substance: A complaint was received for black specks identified as stainless steel inclusions and cellulose with trace amounts of aluminum and iron-rich inclusions.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
Product Codes/Lot Numbers:
Lot #: 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, 68582B, Exp 01/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-133-2013
Related Recalls
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
West-Ward Pharmaceutical
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Failed Impurities/Degradation Specifications; 12 month stability testing.