Class II
Terminated
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
This recall has been terminated (originally issued July 21, 2021).
- Company
- The Harvard Drug Group
- Recall Initiated
- July 2, 2021
- Posted
- July 21, 2021
- Recall Number
- D-0652-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Firm Location
- Livonia, MI, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Distribution
Distributed in OH and NJ
Lot / Code Info
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
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