Recalls / Class III
Class IIID-0506-2019
Product
Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC 0378-5280-01), and b) 500-count bottles (NDC 0378-5280-05), Rx only, Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV, 26505
- Affected lot / code info
- Lot #: 3090167, Exp. October 2019
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 8,159 bottles
- Distribution pattern
- Throughout the United States
Timeline
- Recall initiated
- 2019-02-13
- FDA classified
- 2019-02-15
- Posted by FDA
- 2019-02-27
- Terminated
- 2019-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0506-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.