DICLOFENAC SODIUM AND MISOPROSTOL

Generic: DICLOFENAC SODIUM AND MISOPROSTOL

BluePoint LaboratoriesManufacturer
ORALRoute
DICLOFENAC SODIUMActive Substance
2012-07-09Original Approval

DICLOFENAC SODIUM AND MISOPROSTOL is FDA application ANDA201089, sponsored by ACTAVIS LABS FL INC. 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 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 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 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
27 reports
2
NAUSEA
24 reports
3
DRUG HYPERSENSITIVITY
23 reports
4
INFECTION
22 reports
5
ARTHRALGIA
19 reports
6
FATIGUE
19 reports
7
DIARRHOEA
18 reports
8
PAIN IN EXTREMITY
18 reports
9
LOWER RESPIRATORY TRACT INFECTION
17 reports
10
VOMITING
17 reports