DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL

Generic: DICLOFENAC SODIUM/MISOPROSTOL

Micro Labs LimitedManufacturer
ORALRoute
DICLOFENAC SODIUMActive Substance
2021-07-15Original Approval

DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL is FDA application ANDA204355, sponsored by MICRO LABS. 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
HAEMORRHAGE
1,191 reports
2
ABORTION INCOMPLETE
1,157 reports
3
DRUG INEFFECTIVE
511 reports
4
PAIN
494 reports
5
OFF LABEL USE
493 reports
6
ANAEMIA
450 reports
7
PREGNANCY
435 reports
8
NAUSEA
396 reports
9
DIZZINESS
347 reports
10
VOMITING
343 reports