Diltiazem HCl Extended-release Capsules recall: Impurity Out of Spec
Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan…
Why was Diltiazem HCl Extended-release Capsules recalled?
Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch 3096049
- Product
- Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan…
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Quantity
- 408 cartons
- Distribution
- Nationwide USA
- Recall date
- August 29, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)