FDA Recall D-322-2013
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
Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, 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.
Recall record
- Recall number
D-322-2013- 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