Why it was recalled
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Product description
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
Lot numbers, UPCs & expiration codes
Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.
Where it was sold
Nationwide
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-0630-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 7, 2017
- FDA report date
- Apr 12, 2017
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-0630-2017, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 76664
- Address
- 10 Bloomfield Ave Bldg B Ste 2
- Code information
- Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019.
- Postal code
- 07058-9743
- Report date
- Apr 12, 2017
- Product type
- Drugs
- Recall number
- D-0630-2017
- Classification
- Class III
- Recalling firm
- Alvogen, Inc
- Termination date
- Dec 15, 2017
- Reason for recall
- Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 7, 2017
- Initial firm notification
- Letter
- Center classification date
- Apr 4, 2017