The Recall Desk

FDA (Drugs) recall action 63871

West-ward Pharmaceutical Corp. recalled 2 products on 2013-01-30

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-01-30
Critical
0
Units
75,625

Why these products were recalled

Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets.

Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··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.

    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2013-01-30

    West-ward Recalls Lisinopril Tablets Due to Foreign Substance Presence

    West-ward Pharmaceutical Corp. is recalling specific lots of Lisinopril Tablets, USP 40 mg, because uncharacteristic black spots were found in the tablets.

    Product
    Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-
    Category
    Distribution
    1 state