Mylan Recalls Subpotent Triamterene and Hydrochlorothiazide Tablets Nationwide
Mylan Pharmaceuticals is voluntarily recalling 28,436 bottles of Triamterene and Hydrochlorothiazide Tablets because the medication was found to be subpotent.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Pharmaceuticals Inc. is voluntarily recalling 28,436 bottles of Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottles. The recall was initiated on July 9, 2018, and the product was distributed nationwide within the United States. The specific lot number is 2007979, with an expiration date of 11/30/2020.
The reason for the recall is that the drug was found to be subpotent, meaning it did not contain the full amount of active ingredient required by the United States Pharmacopeia (USP) standards. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Patients who have been prescribed this medication should consult their healthcare provider or pharmacist for guidance on alternative treatments or replacement prescriptions. The recall was terminated on January 16, 2020.
The recalled product
- Product
- Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 28,436
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 (2)
- Lot #: 2007979
- Exp. 11/30/2020
Distribution
Distributed nationwide across the United States.
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