Drug recall D-0652-2021
Product
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
Reason for recall
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Lots and codes
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Recall details
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Distribution
- Distributed in OH and NJ
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 2, 2021
- Terminated
- December 28, 2022
Related products
- nifedipine – drug information
- NDC 0904-7081 Nifedipine · Nifedipine 60 mg/1 · Major Pharmaceuticals
- NDC 0904-7082 Nifedipine · Nifedipine 90 mg/1 · Major Pharmaceuticals