The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-131-2013·Announced 2013-01-30

West-ward Recalls Propylthiouracil Tablets Due to Foreign Substance Presence

West-ward Pharmaceutical Corp. is recalling specific lots of Propylthiouracil Tablets, USP, 50 mg because uncharacteristic spots identified as steel corrosion, degraded tablet material, and hydrocarbon oil were found.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential significant injury or property damage, or structural defects, are categorized as Severe (Score 4).

Plain-English summary

West-ward Pharmaceutical Corp. is recalling Propylthiouracil Tablets, USP, 50 mg, packaged in 100-count and 1000-count bottles. The recall involves 43,075 bottles distributed nationwide and in Puerto Rico. The affected lots are 68478A, 69059A, and 69059B, all with an expiration date of 01/16.

The recall was initiated due to the presence of a foreign substance. Uncharacteristic spots were identified in the tablets as steel corrosion, degraded tablet material, and hydrocarbon oil with trace amounts of iron. The agency has classified this recall as Class II.

Consumers who have these specific lots of Propylthiouracil Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.

The recalled product

Product
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724.
Manufacturer
West-ward Pharmaceutical Corp.
Category
Drug — Tablets
Hazard
Affected units
43,075

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 #: 68478A
  • 69059A
  • 69059B
  • Exp 01/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 2 products in this recall →

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