West-ward Recalls Prednisone Tablets Due to Foreign Substance Presence
West-ward Pharmaceutical Corp. is recalling PredniSONE Tablets, USP, 20 mg, due to the presence of foreign substances including stainless steel inclusions.
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, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard involves foreign substances (stainless steel, cellulose, aluminum, iron) in a drug product, which poses a risk of injury or adverse reaction, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
West-ward Pharmaceutical Corp. is recalling PredniSONE Tablets, USP, 20 mg, in 100-count, 500-count, and 1000-count bottles. The recall is being conducted because a complaint was received regarding the presence of foreign substances in the product.
The foreign substances identified in the complaint include black specks consisting of stainless steel inclusions and cellulose, along with trace amounts of aluminum and iron-rich inclusions. The affected lots are 68581A, 68581B, 68382A, 68382B, 68578A, 68578B, 68579A, 68580A, 68582A, and 68582B, all with an expiration date of 01/15.
A total of 60,289 bottles were distributed nationwide and in Puerto Rico. Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ…
- Manufacturer
- West-ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 60,289
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 (11)
- Lot #: 68581A
- 68581B
- 68382A
- 68382B
- 68578A
- 68578B
- 68579A
- 68580A
- 68582A
- 68582B
- Exp 01/15
Distribution
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