Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Split Tablets
Actavis Laboratories is recalling 5,451 bottles of Diclofenac Sodium and Misoprostol tablets because some contain split or broken tablets.
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 hazard involves physical defects (split/broken tablets) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Actavis Laboratories, FL, Inc. is recalling 5,451 bottles of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count. The recall is due to the presence of split or broken tablets in the product.
The affected product is Lot # 694320A with an expiry date of 02/28/2015. It was distributed nationwide in the United States, including Puerto Rico. The product is a prescription-only medication manufactured by Watson Laboratories, Inc.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
- Brand
- DICLOFENAC SODIUM AND MISOPROSTOL
- Manufacturer
- Actavis Laboratories, FL, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 5,451
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 # 694320A
- Expiry: 02/28/2015.
UPCs (1)
- 305910398606
Distribution
Related recalls
Same brand · DICLOFENAC SODIUM AND MISOPROSTOL
- 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
- ModerateWatson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting
FDA (Drugs) · 2014-02-19
- 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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