Reported Jul 21, 2021 · Terminated
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b)…
The Harvard Drug Group
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Harvard Drug Group · 17187 N Laurel Park Dr Ste 300 · Livonia, MI · 48152-2600
Is this the product you have?
- 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 0904-7080-06Distributed
- byIngenus Pharmaceuticals, LLC Orlando
- FL 32839-6408 Distributed by
Major Pharmaceuticals 17177 N Laurel Park DrSuite 233 LivoniaMI 48152 USA
- Lot codes and dates
- Lots
a)N00418 Exp. 09/2022b) N00417 Exp. 09/2022
- Lots
- Amount recalled
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
Where it was sold
Why it was recalled
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new The Harvard Drug Group recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.