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.
Reported: January 30, 2013 Initiated: December 5, 2012 #D-133-2013
Product 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.
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.
Details
- Recalling Firm
- West-ward Pharmaceutical Corp.
- Units Affected
- 60,289 bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by West-ward Pharmaceutical Corp.. Units affected: 60,289 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 30, 2013. Severity: Moderate. Recall number: D-133-2013.
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