FDAFDA · Food and drugs·Recall number D-1186-2018
Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01
Published September 19, 2018 · Recall initiated: August 7, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Distributed Nationwide in the US
- Lot
- Batch code # 3093163, expiration date 04/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.