Nifedipine Extended-release Tablets recall: Failed Dissolution
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
Why was Nifedipine Extended-release Tablets recalled?
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
- 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
- Recalling firm
- The Harvard Drug Group
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Distribution
- Distributed in OH and NJ
- Recall date
- July 21, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)