West-ward Belladonna Alkaloids with Phenobarbital Tablets Recalled for Foreign Substance
West-Ward Pharmaceutical Corp. is recalling specific lots of Belladonna Alkaloids with Phenobarbital Tablets due to the presence of black specks comprised of degraded organic material.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity recall involving a foreign substance without reported harm.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling 14,503 bottles of West-ward Belladonna Alkaloids with Phenobarbital Tablets. The affected products are prescription-only (Rx only) and are available in 1000-count bottles (NDC 0143-1140-10) and 5000-count bottles (NDC 0143-1140-51). The recall covers Lot # 69098A, 69098B, and 69100A, all with an expiration date of 8/15.
The recall was initiated due to the presence of a foreign substance. Specifically, the tablets contain black specks comprised of degraded organic material. The affected units were distributed nationwide.
Consumers and healthcare providers should check their inventory for the specific NDCs, lot numbers, and expiration dates listed above. If these products are found, they should be returned to the pharmacy or point of purchase for a refund or replacement, or disposed of according to local regulations.
The recalled product
- Product
- West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 14,503
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 (4)
- Lot # 69098A
- 69098B
- 69100A
- Exp 8/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by West-Ward Pharmaceutical Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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