PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 30, 2022 Initiated: July 25, 2022 #D-0068-2023

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

Details

Units Affected
14, 064 (30 sachets in a carton)
Distribution
Nationwide in the USA.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 14, 064 (30 sachets in a carton).
Why was this product recalled?
Discoloration
Which agency issued this recall?
This recall was issued by the FDA Drug on November 30, 2022. Severity: Moderate. Recall number: D-0068-2023.