Recalls / Class II
Class IID-737-2014
Product
Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
- Affected lot / code info
- V110079
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.
Recalling firm
- Firm
- Greenstone Llc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 100 Route 206 North, Peapack, New Jersey 07977
Distribution
- Quantity
- 21600 tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-01
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2015-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-737-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.