Actavis Recalls Cartia XT Capsules Due to Aluminum Residue on Exterior
Actavis is recalling 2,628 bottles of Cartia XT capsules because fine aluminum residue was found on the exterior of the capsule shells.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 III, which the rubric associates with scores of 1 or 2. Given the presence of a foreign substance (aluminum) on the exterior of the capsules, a score of 2 (Moderate) is appropriate as it is a low-risk contamination or labeling/packaging issue rather than a cosmetic defect only.
Plain-English summary
Actavis Laboratories, FL, Inc. is recalling 2,628 bottles of Cartia XT (diltiazem HCl extended-release capsules, USP), 300 mg, 90-count bottles. The recall is due to the presence of a foreign substance, specifically fine residue or dust identified as aluminum, on the exterior of the capsule shell.
The affected product is identified by Lot # 956000M, with an expiration date of August 2016, and UPC 3-6203760090-6. The product was distributed nationwide. The capsules are manufactured by Watson Laboratories, Inc., in Corona, CA, and are available by prescription only.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The recalled product
- Product
- Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
- Manufacturer
- Actavis Laboratories, FL, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 2,628
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 (3)
- Lot # 956000M
- Exp. Aug 2016
- UPC 3-6203760090-6
Distribution
Distributed nationwide across the United States.
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