Macleods Pharma Recalls Telmisartan and Hydrochlorothiazide Tablets for Blend Uniformity
Macleods Pharma USA is recalling Telmisartan and Hydrochlorothiazide tablets because they failed content uniformity specifications for blend uniformity.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a prescription drug with a quality control issue (blend uniformity) and no reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets 80 mg/25 mg, 30-count bottles. The product is manufactured by Macleods Pharmaceuticals Ltd. in India and distributed nationwide within the United States. The recall involves 134,495 bottles with NDC 33342-130-07.
The recall was initiated because the product failed content uniformity specifications, specifically for blend uniformity. This means the active ingredients may not be evenly distributed throughout the tablets.
Consumers with these specific lot numbers should contact their healthcare provider or pharmacist for guidance. The affected lots include BTN703A through BTN814A with expiration dates ranging from February 2019 to September 2020.
The recalled product
- 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
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Affected units
- 134,495
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Macleods Pharma Usa Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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