Matzim LA Extended-Release Tablets Recalled for Dissolution Specification Failure
Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a medication with dissolution specification failure and no reported illnesses or injuries. This represents a risk-of-harm product where injury has not been reported, justifying a High severity score per the rubric.
Plain-English summary
Teva Pharmaceuticals USA Inc. is recalling Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg distributed nationwide in the United States and Puerto Rico. The recall affects 5,677 bottles of the 30-count packages with lot number 1411596A and expiration date 09/22.
The tablets failed to meet dissolution specifications. Testing found that the tablets did not dissolve within the limits specified for this medication.
Patients who are currently taking this medication should consult their healthcare provider before making any changes to their treatment. Those who have this medication in their possession should verify the lot number and speak with their pharmacist or doctor about whether their specific supply is affected.
The recalled product
- Product
- Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Extended-Release Tablet
- Hazard
- Affected units
- 5,677
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 1411596A
- Exp 09/22
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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