FDA Recall D-321-2013

Green Valley Drugs · Henderson, NV

Class I — life-threatening Terminated 164 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV.

Lot / code: Lot #s: 20121105-B, 20121112-G

Quantity: 1395 Vials total; 900x1 ml vials 20121105-B; 90x 2ml vials of lot 20121112-G and 495x1 ml vials of lot 20121112-G.

Reason for recall

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.

Recall record

Recall number: D-321-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2012-12-04
Classified by FDA Center: 2013-05-15
FDA published: 2013-05-22
Terminated: 2013-05-17
Recalling firm: Green Valley Drugs
Firm location: Henderson, NV

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