West-ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance
West-ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital tablets because uncharacteristic black spots were found in the product.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign substance (black spots) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets, a prescription medication. The recall involves 6,511 bottles of the product, which are packaged in 1000-count and 5000-count bottles. The affected lots are 69099A and 69099B, with an expiration date of 08/15.
The recall was initiated due to the presence of a foreign substance, specifically uncharacteristic black spots found in the tablets. The product was distributed nationwide.
Consumers should stop using the recalled tablets and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- 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);
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Tablets
- Hazard
- Affected units
- 6,511
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 69099A
- 69099B
- Exp 08/15
Distribution
Distributed nationwide across the United States.
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