FDAFDA · Food and drugs·Recall number D-170-2013
Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; 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; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Published March 6, 2013 · Recall initiated: January 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- West-ward Pharmaceutical Corp.
- Distributor
- Nationwide
- Lot
- Lot #: 69099A, 69099B, Exp 08/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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