West-Ward Recalls Prednisone Tablets Due to Underweight Specification Failure
West-Ward Pharmaceuticals is recalling 15,109 bottles of Prednisone 1 mg tablets because an underweight tablet was discovered.
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 hazard involves a minor specification failure (underweight tablet) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
West-Ward Pharmaceuticals is recalling 15,109 bottles of PredniSONE Tablets USP, 1 mg, 100-count bottles. The recall was initiated after the discovery of an underweight tablet, which constitutes a failure of tablet specifications.
The affected product is identified by Lot # 660621A with an expiration date of 01/31/18. The product is distributed nationwide in the United States. The NDC for the specific 100-count bottle is 0054-4741-25.
Consumers who have this specific lot of Prednisone should stop using it and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- PREDNISONE (PREDNISONE)
- Brand
- PREDNISONE
- Manufacturer
- West-Ward Pharmaceutical
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 15,109
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 (2)
- Lot # 660621A
- Exp 01/31/18
UPCs (1)
- 0300543722507
Distribution
Distributed nationwide across the United States.
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