The Recall Desk
ModerateFDA (Drugs)·D-817-2013·Announced 2013-07-31

Watson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets

Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because some are broken. Patients should stop using the product and contact their healthcare provider.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect is a physical specification failure (broken tablets) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Watson Laboratories, Inc. is recalling Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottles. The recall is due to tablets that are broken.

The affected product is identified by Lot 635098A with an expiration date of 10/14. The NDC is 0591-0398-60. The product was distributed nationwide.

Patients who have this medication should stop using it and contact their healthcare provider for further instructions.

The recalled product

Product
DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Brand
DICLOFENAC SODIUM AND MISOPROSTOL
Manufacturer
Watson Laboratories, Inc.-(Actavis) - Florida
Category
Drug — Prescription Drug
Hazard
Affected units
392,400

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 635098A
  • Exp 10/14

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DICLOFENAC SODIUM AND MISOPROSTOL

Same hazard · physical defect

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