D-0652-2021 Class II Terminated
FDA drug recall D-0652-2021 was initiated by The Harvard Drug Group on July 2, 2021 and is designated Class II. Reason for recall: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. The recall status is terminated (terminated December 28, 2022). Affected quantity: 504 Cartons of 50 count each; 372 Cartons of 100 count each.
Recall Details
- Product Type
- Drugs
- Report Date
- July 21, 2021
- Initiation Date
- July 2, 2021
- Termination Date
- December 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
Product Description
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.
Distribution Pattern
Distributed in OH and NJ
Code Information
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022