Reported Mar 6, 2013 · Terminated
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065…
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?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg |
| 2 | atropine sulfate, USP 0.0194 mg |
| 3 | scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10 |
| 4 | 5000-count tablets per bottle (NDC 143-1140-51) |
| 5 | Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 |
- Lot codes and dates
Lot #: 69099A69099BExp 08/15
- Amount recalled
- 6,511 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
This product could cause temporary or reversible health problems — stop using it.
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