Reported Nov 30, 2022 · Terminated

Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in apple juice or applesauce only Each packet…

Sun Pharmaceutical Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620

Is this the product you have?

  • 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 bySun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
  • manufactured bySun Pharmaceutical Industries Limited Mohali, INDIA, NDC 62756-071-60
Lot codes and dates
    • Lot #: MHC1317A
    • Exp 07/2023
Amount recalled
14, 064 (30 sachets in a carton)

Where it was sold

  • Nationwide

Why it was recalled

Discoloration

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 13, 2023 · Data as of Sep 19, 6:37 PM UTC

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