Class III
Terminated
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
This recall has been terminated (originally issued February 27, 2019).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- February 13, 2019
- Posted
- February 27, 2019
- Recall Number
- D-0506-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8,159 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Distribution
Throughout the United States
Lot / Code Info
Lot #: 3090167, Exp. October 2019
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