FDA recall D-321-2013

Green Valley Drugs · Class I · drug

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.

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.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2012-12-04
Report date
2013-05-22
Termination date
2013-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Henderson, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-321-2013