DICLOFENAC SODIUM

Generic: DICLOFENAC SODIUM

Sandoz IncManufacturer
OPHTHALMICRoute
DICLOFENAC SODIUMActive Substance
2008-02-06Original Approval

DICLOFENAC SODIUM is FDA application ANDA078031, sponsored by SANDOZ. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2013-03-22
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc

Failed Tablet/Capsule Specifications: Broken tablets

Class III2025-12-22
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Stre

Failed PH Specifications

Class II2014-09-26
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Wats

Failed Tablet/Capsule Specifications: Presence of split or broken tablets.

Class II2014-04-24
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Wats

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Class II2013-03-22
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson

Failed Tablet/Capsule Specifications: Broken tablets

Class II2026-01-27
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result i

Class II2013-12-20
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Wats

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Class II2023-06-22
Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharm

Defective Delivery System

Class II2014-04-24
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 50 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Wats

Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets.

Top Reported Reactions

1
DRUG INEFFECTIVE
14,320 reports
2
PAIN
12,795 reports
3
FATIGUE
11,824 reports
4
RHEUMATOID ARTHRITIS
9,629 reports
5
OFF LABEL USE
9,256 reports
6
RASH
9,206 reports
7
ARTHRALGIA
9,129 reports
8
ABDOMINAL DISCOMFORT
8,823 reports
9
ALOPECIA
8,326 reports
10
JOINT SWELLING
8,132 reports