Recalls / Class III
Class IIID-1435-2014
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.
- Affected lot / code info
- Lot #: 3045659, 3048256, Exp 07/14
Why it was recalled
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 1,184 cartons
- Distribution pattern
- Nationwide, Puerto Rico, and Guam.
Timeline
- Recall initiated
- 2014-07-03
- FDA classified
- 2014-07-17
- Posted by FDA
- 2014-07-23
- Terminated
- 2016-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1435-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.