Drug Enforcement D-321-2013

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.

Status

Terminated

Classification

Class I

Report Date

May 22, 2013

Termination Date

May 17, 2013

Product Information

Product description
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.
Product 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 initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide

Location & Firm

Recalling firm
Green Valley Drugs
Address
1850 Whitney Mesa Dr, Suite 180

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-321-2013
Event ID
63953
Recall initiation date
December 4, 2012
Center classification date
May 15, 2013
Code info
Lot #s: 20121105-B, 20121112-G
More code info