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Showing 8181–8200 of 15081 results

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Novacort Gel Packets (Novum Pharma) – Subpotent Drug (2016)

Subpotent Drug: Out of specification result for pramoxine hydrochloride

Class IIILow

FDADec 7, 2016Nationwide• Novum Pharma, LLC

Fluconazole Injection (Baxter Healthcare) – Sterility Concern (2016)

Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.

Class IIModerate

FDADec 6, 2016Nationwide• Baxter Healthcare Corporation

Premasol Amino Acid Injection (Baxter Healthcare) – Discoloration (2016)

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Class IIModerate

FDADec 6, 2016Nationwide• Baxter Healthcare Corporation

INOVA Easy Pad (Cipher Pharmaceuticals) – Subpotent Formulation (2016)

Subpotent Drug: Product label claim is 4% Benzoyl Peroxide, Initial Stability testing showed variation within the lot outside of product specifications.

Class IIILow

FDADec 6, 2016AZ, CO, OH• Cipher Pharmaceuticals US LLC

Pentasa Capsules (Shire PLC) – Incorrect Tablet Mix (2016)

Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules

Class IIILow

FDADec 2, 2016Nationwide• Shire PLC

Risedronate Sodium Tablets (Teva) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIILow

FDADec 1, 2016Nationwide• Teva Pharmaceuticals USA

MegaJex Herbal Supplement (MS Bionic) – Undeclared Pharmaceuticals (2016)

Marketed without an Approved NDA/ANDA; product contains sildenafil and tadalafil which are active pharmaceutical ingredients in FDA approved drugs used to treat erectile dysfunction (ED)

Class IHigh

FDANov 30, 2016CA• MS Bionic

Domperidone Capsules (Jeffreys Drug Store) – Unapproved Medication (2016)

Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

Class IHigh

FDANov 23, 2016PA• Jeffreys Drug Store

PROTONIX I.V. (Pfizer) – Subpotent Injection (2016)

Subpotent Drug: Out of Specification (OOS) for potency at the 6-month stability time point.

Class IIILow

FDANov 22, 2016Nationwide• Pfizer Inc.