Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency
Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.
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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 1,620 bottles of Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/25 mg, 100-count bottles. The affected product is prescription-only and carries NDC 0378-0464-01. The specific lot number is 3087136, with an expiration date of 5/20.
The recall was initiated because composite assay results obtained during routine stability testing indicated that the drug potency was slightly above the established specification. This is classified as a superpotent drug issue.
The product was distributed throughout the United States. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If the product is found, it should be returned to the pharmacy or point of purchase for disposal or replacement, as directed by the recalling firm.
The recalled product
- Product
- Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,620
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 #: 3087136
- Exp 5/20
Distribution
Distribution scope not specified by the agency.
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