Diltiazem HCl Extended-release Capsules recall: Impurity Out of Spec
Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
Why was Diltiazem HCl Extended-release Capsules recalled?
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
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?
Lot #: 3045659, 3048256, Exp 07/14
- Product
- Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Quantity
- 1,184 cartons
- Distribution
- Nationwide, Puerto Rico, and Guam.
- Recall date
- July 23, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)