Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
Lot numbers, UPCs & expiration codes
Lot # 0598B151; Exp 03/18
Where it was sold
US
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-0143-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 6, 2016
- FDA report date
- Nov 30, 2016
- Quantity
- 27,517 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis Elizabeth LLC
Original FDA data
Every field from FDA enforcement report D-0143-2017, exactly as published.
Show all FDA fields
- City
- Elizabeth
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75445
- Address
- 200 Elmora Ave
- Code information
- Lot # 0598B151; Exp 03/18
- Postal code
- 07202-1106
- Report date
- Nov 30, 2016
- Product type
- Drugs
- Recall number
- D-0143-2017
- Classification
- Class III
- Recalling firm
- Actavis Elizabeth LLC
- Product quantity
- 27,517 bottles
- Termination date
- May 8, 2017
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-2407-10
- Distribution pattern
- US
- Recall initiation date
- Oct 6, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 18, 2016