June 2022 FDA Recall Drug by Glenmark Pharmaceuticals Inc., Usa
D-1171-2022 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on June 29, 2022 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in One sole distributor in TX and the recall is currently terminated.
Recall Number: D-1171-2022
CGMP Deviations
06-29-2022
07-06-2022
36 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.
Glenmark Pharmaceuticals Inc., USA
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.
One sole distributor in TX
06-23-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India, NDC 16714-884-01
Batch or Lot Expiration Information
Lot# : 20020121, Exp 01/2024
