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Testosterone Cypionate Injection (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Alprostadil IN NS Injection (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide

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Testosterone Cypionate Injection (Pallimed Solutions) – Sterility Concerns (2013)

Alprostadil IN NS Injection (Pallimed Solutions) – Sterility Concerns (2013)

MIC with B6 and B12 (Pallimed Solutions) – Sterility Concerns (2013)

Trimix Injection (Pallimed Solutions) – Sterility Concerns (2013)

Nandrolone Decanoate Injectable (Pallimed Solutions) – Sterility Concerns (2013)

Dexamethasone PF (Pallimed Solutions) – Sterility Concerns (2013)

Cidofovir Opthalmic Solution (Pallimed Solutions) – Sterility Concerns (2013)

Atropine Injection (Pallimed Solutions) – Sterility Concerns (2013)

Hydroxyprogesterone CAPR.(G.S.) (Pallimed Solutions) – Sterility Concerns (2013)

Diazepam Injectable (Pallimed Solutions) – Sterility Concerns (2013)

BiMix Injection (Pallimed) – Sterility Concerns (2013)

Testosterone Cypionate/Testosterone Enanthate Injection (Pallimed Solutions) – Sterility Concerns...

Cyclosporine Ophthalmic (Pallimed Solutions) – Sterility Concerns (2013)

Methylcobalamin PF (Pallimed) – Sterility Concerns (2013)

HCG Chorionic Gonadotropin (Pallimed Solutions) – Sterility Concerns (2013)

Verapamil Injection (Pallimed) – Sterility Concerns (2013)

Diclofenac Sodium Misoprostol Tablets (Watson) – Broken Tablets (2013)

Bupropion Hydrochloride Tablets XL (Actavis) – Dissolution Failure (2013)

Diclofenac Sodium Misoprostol Tablets (Actavis) – Broken Tablets (2013)

Children's Acetaminophen Suspension (Precision Dose) – Misleading Labeling (2013)