Reported Aug 2, 2023 · Ongoing

Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic…

Alembic Pharmaceuticals, 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: ALEMBIC PHARMACEUTICALS, INC. · 550 Hills Dr Ste 104b · Bedminster, NJ · 07921-1537

Is this the product you have?

  • Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only
  • Manufactured forAlembic Pharmaceuticals, Inc. Bedminster, NJ 07921
  • USA Manufactured byAlembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12
Lot codes and dates
    • Lot #: 220151
    • 220152
    • 220153
    • Exp. Date 11/2024
Amount recalled
2844 units

Where it was sold

  • Nationwide

Why it was recalled

Defective Delivery System

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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