Recalls / Class II
Class IID-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
- Brand name
- Nifedipine
- Generic name
- Nifedipine
- Active ingredient
- Nifedipine
- Route
- Oral
- NDCs
- 0904-7081, 0904-7080, 0904-7082
- FDA application
- ANDA210614
- Affected lot / code info
- Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Why it was recalled
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Recalling firm
- Firm
- The Harvard Drug Group
- Manufacturer
- Major Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Distribution pattern
- Distributed in OH and NJ
Timeline
- Recall initiated
- 2021-07-02
- FDA classified
- 2021-07-09
- Posted by FDA
- 2021-07-21
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0652-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.