FDAFDA · Food and drugs·Recall number D-0652-2021
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
Published July 21, 2021 · Recall initiated: July 2, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NIFEDIPINE
- Manufacturer
- The Harvard Drug Group
- Distributor
- Distributed in OH and NJ
- UPC
- 0309047080069
- Lot
- Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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