Recalls / Class III
Class IIID-1557-2014
Product
Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
- Affected lot / code info
- Lot 3040063 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 Pharmaceuticals Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 2,658 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-19
- FDA classified
- 2014-08-22
- Posted by FDA
- 2014-09-03
- Terminated
- 2015-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1557-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.