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%.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Tablet/Capsule Specifications: Broken tablets
What was recalled
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
- Recalling firm
- Watson Laboratories, Inc.-(Actavis) - Florida
- NDC code
- 0591-0398-60
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-817-2013
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 III · Low risk Ongoing
Diclofenac Sodium Topical Gel
Reason Failed PH Specifications
Class II · Moderate risk Ongoing
Diclofenac Sodium Topical Solution USP
Reason Defective Delivery System
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.
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.
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