Drugplain

nifedipine 30 mg/1

nifedipine · TABLET, FILM COATED, EXTENDED RELEASE · Oceanside Pharmaceuticals

10 Recalls on Record
Plain English

nifedipine is a tablet, film coated, extended release containing nifedipine at 30 mg/1, taken oral. Manufactured by Oceanside Pharmaceuticals.

Key Facts

Brand Name
nifedipine
Generic Name
nifedipine
NDC Code (Product)
68682-108
Manufacturer
Oceanside Pharmaceuticals
Strength
30 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA075289
Drug Class
Dihydropyridine Calcium Channel Blocker [EPC]
Marketing Start
09/27/2000

Recall History

10 Recalls on Record
Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013.

TerminatedVoluntary: Firm initiated
Class III03/07/2017

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

TerminatedVoluntary: Firm initiated
Class II11/01/2013

Greenstone Llc

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.

TerminatedVoluntary: Firm initiated
Class III03/07/2017

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

TerminatedVoluntary: Firm initiated
Class III10/13/2016

Amerisource Health Services

Presence of Foreign Tablets/Capsules

TerminatedVoluntary: Firm initiated
Class II03/25/2016

Reliable Rexall-A Compounding Pharmacy

Lack of Processing Controls

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC 47781030301, Pedigree: AD52778_58, EXP: 5/20/2014.

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W003749, EXP: 6/26/2014.

TerminatedVoluntary: Firm initiated
Class III03/07/2017

Alvogen, Inc

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,267 reports
dyspnoea2,146 reports
diarrhoea2,067 reports
fatigue2,024 reports
off label use1,913 reports
nausea1,907 reports
headache1,708 reports
hypertension1,530 reports
dizziness1,517 reports
pain1,387 reports

Frequently Asked Questions

What is nifedipine used for?

nifedipine contains nifedipine. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.

Is nifedipine a controlled substance?

nifedipine is not classified as a controlled substance by the DEA.

What is the generic name for nifedipine?

The generic name for nifedipine is nifedipine. There are 12 other brand versions of nifedipine.

What is the NDC code for nifedipine 30 mg/1?

The NDC (National Drug Code) for nifedipine 30 mg/1 is 68682-108, listed by Oceanside Pharmaceuticals.