D-0068-2023 Class II Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
November 30, 2022
Initiation Date
July 25, 2022
Termination Date
September 13, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14, 064 (30 sachets in a carton)

Product Description

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

Reason for Recall

Discoloration

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: MHC1317A, Exp 07/2023