Recalls / Class II
Class IID-1003-2019
Product
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
- Affected lot / code info
- Lot #: BTL703A, Exp. Feb-19; BTL705A, Exp Apr-19; BTL706A, BTL707A, BTL708A, Exp May-19; BTL709A, Exp Nov-19; BTL710A, BTL711A, BTL801A, Exp. Dec-19; BTL802A, BTL803A, Exp.Feb-20; BTL804A, BTL805A, Exp. Apr-20; BTL807A, BTL807B, Exp May- 20; BTL809A, BTL810A, Exp Jul-20; BTL811A, Exp Sep-20; BTL812A, BTL813A Exp Oct-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
- 93227 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-1003-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.