CLASS I Drug recall · Reported 22 May 2013 · FDA Enforcement Report
Methylprednisolone Preservative Free 40 mg/ml Injectible recalled
Green Valley Drugs is recalling Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension Vials and Vials and, distributed nationwide in the US. The recall was initiated on 4 Dec 2012 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-321-2013
- FDA event ID
- 63953
- Recalling firm
- Green Valley Drugs, Henderson, NV
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Dec 2012
- FDA classified
- 15 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Dec 2012 | Recall initiated by company | |
| 15 May 2013 | Classified by FDA | +162 days |
| 22 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #s: 20121105-B, 20121112-G
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 63953This product is part of a recall event; the main page for the event is Cyanocobalamin 1000 mcg/ml, injection, MDV recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Cyanocobalamin 1000 mcg/ml, injection, MDV recalled | Green Valley Drugs | Sterility | Nationwide |
More recalls from Green Valley Drugs
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cyanocobalamin 1000 mcg/ml, injection, MDV recalled | Green Valley Drugs | Sterility | Nationwide |