Reported Jan 30, 2013 · Terminated
PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets…
West-ward Pharmaceutical Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: West-ward Pharmaceutical Corp. · 465 Industrial Way W · Eatontown, NJ · 07724-2209
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 100-count tablets per bottle (NDC 0143-1477-01) |
| 2 | 500-count tablets per bottle (NDC 0143-1477-05), and |
| 3 | 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. |
- Lot codes and dates
Lot #: 68581A68581B68382A68382B68578A68578B68579A68580A68582A68582BExp 01/15
- Amount recalled
- 60,289 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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