FDA-Drug2013-03-06Class II
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
West-ward Pharmaceutical Corp.
Hazard
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Sold states
Nationwide
Affected count
6,511 bottles
Manufactured in
465 Industrial Way W, N/A, Eatontown, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-170-2013Don't want to check this manually?
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