July 2022 FDA Recall Pantoprazole Sodium by Sun Pharmaceutical Industries Inc
D-0068-2023 - Discoloration

This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on July 25, 2022 for the product Pantoprazole Sodium. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0068-2023

Reason for Recall
Discoloration
Initiated
07-25-2022
Reported
11-30-2022
Quantity
14, 064 (30 sachets in a carton)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91146
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2023
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet contains 40 mg pantoprazole equivalent to 45.1 mg of pantoprazole sodium USP (sesquihydrate), Rx Only, distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60

Batch or Lot Expiration Information

Lot# : MHC1317A, Exp 07/2023

Affected Packages Involved in this Recall

62756-071-60 Pantoprazole Sodium
62756-071-64 Pantoprazole Sodium