Why it was recalled
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Product description
Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
Lot numbers, UPCs & expiration codes
Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1004-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 25, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 140,589 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1004-2019, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82196
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #: BTM703A, BTM704A, BTM706A, BTM707A, Exp Feb-19; TM708A,BTM709A, Exp Apr-19; BTM710A, Exp Jun-19; BTM711A, BTM712A, Exp Oct-19; BTM713A,BTM714A, BTM715A, Exp Nov-19; BTM801A, BTM802A, BTM803A, BTM804A, Exp Dec-19; BTM806A,BTM807A, Exp Mar-20; BTM809A Exp Apr-20; BTM810A, BTM811A, BTM812A, Exp. Jul-20; BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, Exp Sep-20; BTM818A, BTM819A Exp Nov-20.
- Postal code
- 08536-0009
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1004-2019
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 140,589 bottles
- Termination date
- Jul 12, 2021
- Reason for recall
- Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Feb 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2019