Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials an...
FDA Recall #D-321-2013 — Class I — December 4, 2012
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.
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.
Recalling Firm
Green Valley Drugs — Henderson, NV
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
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.
Distribution
Nationwide
Code Information
Lot #s: 20121105-B, 20121112-G
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated