The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1082-2014·Announced 2014-02-19

Watson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because split tablets were found in stability samples.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

Watson Laboratories, Inc. is recalling Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottles. The recall involves 5,987 bottles of the prescription medication, identified by Lot# 605957A and an expiration date of 09/14. The product was distributed nationwide.

The recall was initiated because split tablets were found in 12-month stability samples. This failure in tablet specifications indicates a potential quality issue with the physical integrity of the medication.

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

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 Medication
Hazard
Affected units
5,987

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# 605957A
  • Exp 09/14

UPCs (1)

  • 305910398606

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · DICLOFENAC SODIUM AND MISOPROSTOL

Same hazard · physical defect

See all →

Similar recalls