The Recall Desk

FDA (Drugs) recall action 90635

Teva Pharmaceuticals USA Inc recalled 2 products on 2022-08-10

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
2022-08-10
Critical
0
Units
13,699

Why these products were recalled

Failed Dissolution Specifications: below specification limits for dissolution.

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

  • HighFDA (Drugs)··2022-08-10

    Matzim LA Extended-Release Tablets Recalled for Dissolution Specification Failure

    Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.

    Product
    Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2022-08-10

    Prescription Drug Matzim LA Extended-Release Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals is recalling Matzim LA (Diltiazem Hydrochloride) 180 mg tablets because they failed to meet dissolution specifications. The recall affects approximately 8,022 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Distribution
    1 state