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.
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, 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
- ModerateActavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Split Tablets
FDA (Drugs) · 2014-12-03
- ModerateActavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting
FDA (Drugs) · 2014-10-08
- ModerateActavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting
FDA (Drugs) · 2014-10-08
- ModerateActavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets
FDA (Drugs) · 2014-02-12
- ModerateWatson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets
FDA (Drugs) · 2013-07-31
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