Recalls / Class II
Class IID-1005-2019
Product
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
- Affected lot / code info
- Lot #: BTN703A, BTN704A Exp Feb-19; BTN705A, BTN706A, Exp May-19; BTN707A, Exp Jun-19; BTN810A, Exp Jun-20; BTN811A, BTN812A Exp Aug-20; BTN813A, BTN814A, Exp Sep-20; BTN802A, BTN802B, BTN803A, BTN804A, Exp Dec-19; BTN805A, BTN806A, BTN807A, BTN807B, Exp Feb-20; BTN808A, Exp Apr-20; BTN809A, BTN810A, Exp Jun-20; BTN811A, BTN812A, Exp Aug-20; BTN813A, BTN814A, Exp Sep-20.
Why it was recalled
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 134495 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-02-25
- FDA classified
- 2019-03-14
- Posted by FDA
- 2019-03-20
- Terminated
- 2021-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1005-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.