Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma U…
- Recall date
- February 25, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1003-2019
- FDA classification
- Class II
- Brand / firm
- Macleods Pharma Usa Inc
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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