Why it was recalled
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
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
Lot numbers, UPCs & expiration codes
Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
Where it was sold
Distributed in OH and NJ
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0652-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2021
- FDA report date
- Jul 21, 2021
- Quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group
Original FDA data
Every field from FDA enforcement report D-0652-2021, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 88224
- Address
- 17187 N Laurel Park Dr Ste 300
- Code information
- Lots: a)N00418 Exp. 09/2022, b) N00417 Exp. 09/2022
- Postal code
- 48152-2600
- Report date
- Jul 21, 2021
- Product type
- Drugs
- Recall number
- D-0652-2021
- Classification
- Class II
- Recalling firm
- The Harvard Drug Group
- Product quantity
- 504 Cartons of 50 count each; 372 Cartons of 100 count each
- Termination date
- Dec 28, 2022
- Reason for recall
- Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed in OH and NJ
- Recall initiation date
- Jul 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2021