Watson Pharmaceuticals Recalls Taztia XT Due to Dissolution Failure
Watson Pharmaceuticals is recalling Taztia XT (diltiazem HCI) capsules because stability testing revealed a failed dissolution specification.
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, and the hazard involves a quality control failure (dissolution) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Watson Pharmaceuticals is recalling Taztia XT (diltiazem HCI extended release capsules, 360 mg) due to a failed dissolution specification. The recall involves 3,040 bottles of the medication, identified by Lot # 512146A with an expiration date of 01/31/2014.
The recall was initiated after a specification result occurred during 3-month stability testing. Specifically, the dissolution result at the 4-hour time point was 41%, which exceeded the required specification range of 20-40%. This indicates that the medication may not release the active ingredient at the intended rate.
The affected product was distributed nationwide and in Puerto Rico. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatment options.
The recalled product
- Product
- Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
- Manufacturer
- Watson Pharmaceuticals
- Category
- Drug — Cardiovascular
- Hazard
- Affected units
- 3,040
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 #: 512146A
- Exp 01/31/2014
Distribution
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