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Methylprednisolone Injection (Green Valley) - non-sterile (2012)

Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.

Class IHigh

FDADec 4, 2012Nationwide• Green Valley Drugs

Dextroamphetamine Capsules (Amedra) - dissolution failure (2012)

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Class IIModerate

FDADec 4, 2012Nationwide

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Methylprednisolone Injection (Green Valley) - non-sterile (2012)

Dextroamphetamine Capsules (Amedra) - dissolution failure (2012)

Lisinopril Hydrochlorothiazide (West-ward) - steel particulates (2012)

Ethambutol Tablets (West-ward) - tablet discoloration (2012)

Carisoprodol Tablets (West-ward) - DEA schedule change (2012)

TORISEL Injection (Pfizer) – sterility risk (2012)

Nalbuphine HCl Injection (Hospira) – sterility concern (2012)

Derma-Smoothe/FS Scalp Oil (Hill) – subpotent medication (2012)

Derma-Smoothe/FS Body Oil (Hill) – subpotent medication (2012)

Fluorouracil Topical Cream (Taro) – stability issues (2012)

Isovue-300 Injection (Bracco) – particulate matter (2012)

Isovue-370 Injection (Bracco) – particulate matter (2012)

Propranolol Extended-release Capsules (Upsher) – dissolution failure (2012)

Propofol Injectable Emulsion (Hospira) – particulate matter (2012)

Atorvastatin Tablets 20mg (Ranbaxy) – glass particulates (2012)

Atorvastatin Tablets 10mg (Ranbaxy) – glass particulates (2012)

Atorvastatin Tablets 40mg (Ranbaxy) – glass particulates (2012)

Carboplatin Injection 450mg (Hospira) – crystallization risk (2012)

Carboplatin Injection 600mg (Hospira) – crystallization risk (2012)

Clinical LIVE Immune Support (Reaction Nutrition) – undeclared dairy (2012)