Reported Apr 19, 2023 · Ongoing

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber…

Hetero USA 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: Hetero USA Inc · 1035 Centennial Ave · Piscataway, NJ · 08854-4124

Is this the product you have?

  • Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only
  • Manufactured forCamber Pharmaceuticals Inc., Piscataway, NJ, 08854
  • ByHetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10
Lot codes and dates
  • Lot #: PAN22542, Exp
  • Date9/2024
Amount recalled
2,352 bottles

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: 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

Data as of Sep 19, 8:07 PM UTC

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