The Recall Desk

FDA (Drugs) recall action 68069

Teva Pharmaceuticals USA recalled 2 products on 2014-05-28

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
2014-05-28
Critical
0
Units
70,633

Why these products were recalled

Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing.

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)··2014-05-28

    Teva Recalls Buprenorphine Hydrochloride Sublingual Tablets Due to Impurity Failures

    Teva Pharmaceuticals is recalling 17,181 bottles of 2 mg Buprenorphine Hydrochloride Sublingual Tablets because stability testing revealed high out-of-specification impurity levels.

    Product
    BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2014-05-28

    Teva Recalls Buprenorphine Hydrochloride Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 53,452 bottles of 8 mg Buprenorphine Hydrochloride sublingual tablets because stability testing revealed high out-of-specification impurity levels.

    Product
    BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2.
    Category
    Distribution
    1 state