August 2023 FDA Recall Drug by Aurobindo Pharma Usa Inc.
D-1171-2023 - Failed dissolution specifications - results obtained were below spec average.
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on August 2, 2023 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications - results obtained were below spec average.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1171-2023
Failed dissolution specifications - results obtained were below spec average.
08-02-2023
09-27-2023
9,890 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Aurobindo Pharma USA 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.
USA nationwide
08-19-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Batch or Lot Expiration Information
Lot# : 3112444, Exp 8/2023
