February 2022 FDA Recall Chlorthalidone by Sun Pharmaceutical Industries Inc
D-0578-2022 - Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on February 7, 2022 for the product Chlorthalidone. The FDA reported the reason for recall as foreign matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0578-2022

Reason for Recall
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Initiated
02-07-2022
Reported
02-23-2022
Quantity
59,232 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89529
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide with the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-17-2023
Product Description About Product Description
Full technical description of the product.
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.

Batch or Lot Expiration Information

Lot# : P0602, Exp. Date 03/2023

Affected Packages Involved in this Recall

57664-648-88 Chlorthalidone
57664-648-18 Chlorthalidone
57664-649-88 Chlorthalidone
57664-649-18 Chlorthalidone