Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason Superpotent; Hydrochlorothiazide
Reason Subpotent Drug
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