Recalls / Class III
Class IIID-1187-2018
Product
Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05
- Affected lot / code info
- Batch code # 3093163, expiration date 04/2019
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 656 500-count bottles
- Distribution pattern
- Distributed Nationwide in the US
Timeline
- Recall initiated
- 2018-08-07
- FDA classified
- 2018-09-10
- Posted by FDA
- 2018-09-19
- Terminated
- 2019-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1187-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.