US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 9, 2018 (9 years ago)

Diclofenac Sodium USP for prescription compounding

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

What was recalled

Diclofenac Sodium USP for prescription compounding, packaged in a) 25g (NDC 58597-8012-4); b)100g (NDC 58597-8012-6); c) 500 g (NDC 58597-8012-7); d) 1000g (NDC 58597-8012-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327

Recalling firm
American Pharmaceutical Ingredients LLC
NDC code
58597-8012-4
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0484-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Diclofenac recalls

See all
Class II · Moderate risk Ongoing

Diclofenac Sodium

Reason Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

Sun Pharmaceutical Industries INC NDC 51672-1363-7 D-0342-2026
Class II · Moderate risk Terminated

Diclofenac Sodium Topical Solution 1.5% w/w

Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.

Preferred Pharmaceuticals, Inc. NDC 68788-7918-01 D-0773-2022
Class II · Moderate risk Terminated

Diclofenac Sodium Topical Solution USP

Reason cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Teligent Pharma, Inc. NDC 70512-025-05 D-0680-2022