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
Reported: March 20, 2019 Initiated: February 25, 2019 #D-1004-2019
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
Reason for Recall
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 140,589 bottles
- Distribution
- Nationwide within the United States
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Macleods Pharma Usa Inc. Units affected: 140,589 bottles.
Why was this product recalled? ▼
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Moderate. Recall number: D-1004-2019.
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