Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets
Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol tablets because some tablets are broken.
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 involves a situation that may cause temporary or medically reversible adverse health consequences. The specific defect is broken tablets, which is a quality issue rather than a high-risk contamination or mislabeling of allergens.
Plain-English summary
Actavis Inc is recalling 6,540 bottles of Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, NDC 0591-0398-60. The recall is due to tablets that failed specifications by being broken.
The affected product is distributed nationwide. The specific lots involved are Lot 668271A with an expiration date of 11/14 and Lot 684119A with an expiration date of 01/2015. The product is manufactured by Watson Laboratories, Inc., in Corona, CA.
Consumers should check their medication for these specific lot numbers and expiration dates. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
- Brand
- DICLOFENAC SODIUM AND MISOPROSTOL
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 6,540
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 668271A
- Exp 11/14 and Lot 684119A Exp 01/2015
Distribution
Distributed nationwide across the United States.
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