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Recall archive

94,355 stored notices, from Jun 20, 2012 to Sep 23, 2026.

10 recalls · page 1 of 1

Drugs

Reported Dec 20, 2023

Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Siegfried Barbera, SL

Matched: Product detailsFailed Dissolution Specifications

FDA (openFDA drug enforcement)

Drugs

Reported Sep 27, 2023

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product detailsCrystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

FDA (openFDA drug enforcement)

Drugs

Reported May 29, 2019

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New…

High riskUsing this product could cause serious injury, illness or death — stop using it now.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product · Product detailsCross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

FDA (openFDA drug enforcement)

Drugs

Reported May 3, 2017

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by:…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: BrandFailed Impurities/Degradation Specifications.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Sep 23, 2015

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: BrandFailed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution…

FDA (openFDA drug enforcement)

Drugs

Reported Jun 24, 2015

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product detailsFailed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Aug 13, 2014

Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product detailsFailed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

FDA (openFDA drug enforcement)

Drugs

Reported Jun 25, 2014

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for:…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product detailsFailed Stability Specification; out of specification result for particle size distribution during stability testing

FDA (openFDA drug enforcement)

Drugs

Reported Apr 16, 2014

Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp.…

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product · Product detailsLabeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with…

1 more product in this recall

FDA (openFDA drug enforcement)

Drugs

Reported Dec 18, 2013

Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle, Rx only Physician Sample Not For Sale, Manufactured by:…

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

Novartis Pharmaceuticals Corp.

Matched: Brand · Product details · Reason for recallChemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL,…

14 more products in this recall

FDA (openFDA drug enforcement)

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