June 2022 FDA Recall Eszopiclone by Macleods Pharma Usa Inc
D-1174-2022 - Shortfill
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa Inc on June 16, 2022 for the product Eszopiclone. The FDA reported the reason for recall as shortfill. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1174-2022
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
06-16-2022
07-13-2022
168690 Tablets
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.
Macleods 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.
Distributed Nationwide and Puerto Rico.
03-20-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
Batch or Lot Expiration Information
Lot# : BEK2009A Exp: 11/2023
