Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
Product description
Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
Lot numbers, UPCs & expiration codes
V110079
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-737-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 1, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 21600 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Greenstone Llc
Original FDA data
Every field from FDA enforcement report D-737-2014, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66760
- Address
- 100 Route 206 North
- Code information
- V110079
- Postal code
- 07977
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-737-2014
- Classification
- Class II
- Recalling firm
- Greenstone Llc
- Product quantity
- 21600 tablets
- Termination date
- Jun 5, 2015
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 1, 2013
- Initial firm notification
- Telephone
- Center classification date
- Jan 16, 2014