June 2018 FDA Recall Drug by Mylan Pharmaceuticals Inc.
D-0877-2018 - Superpotent Drug
This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on June 7, 2018 for the product Drug. The FDA reported the reason for recall as superpotent drug. The product was distributed in Product was distributed throughout the United States and the recall is currently terminated.
Recall Number: D-0877-2018
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
06-07-2018
06-20-2018
1,620 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed throughout the United States
06-20-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 3087136, Exp 5/20
