Class I · High risk Terminated
Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704
Reason Subpotent and Superpotent Drug
Is Nifedipine recalled?
21 FDA recalls mention Nifedipine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nifedipine.
Class II · Moderate risk Terminated
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count…
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk Terminated
Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA…
Reason Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Class III · Low risk Terminated
AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only…
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and distributed by: Actavis Elizabeth LLC, 200 Elmora…
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
All nifedipine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA…
Reason Lack of Processing Controls
Class II · Moderate risk Terminated
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA…
Reason Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Class II · Moderate risk Terminated
Nifedipine 0.2% - Lidocaine 2% Jelly, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control…
Class II · Moderate risk Terminated
Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on…
Class II · Moderate risk Terminated
NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591319401.
Reason Labeling: Label Mixup: NIFEdipine ER, Tablet, 60 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, LOZENGE, 2 mg…
Class II · Moderate risk Terminated
NIFEdipine Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762100401
Reason Labeling:Label Mixup; NIFEdipine, Capsule, 10 mg may be potentially mislabeled as NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg, NDC…
Class II · Moderate risk Terminated
NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024
Reason Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F)…
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