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FDA · Drug recall

Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension… and 1 more product

May 22, 2013 Class I

Date
May 22, 2013
Risk class
Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
Status
Terminated
Filed by
Green Valley Drugs
Reason
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 pattern
Nationwide

2 products in this recall

Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension…

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.
Quantity
1395 Vials total; 900x1 ml vials 20121105-B; 90x 2ml vials of lot 20121112-G and 495x1 ml vials of lot 20121112-G.
Codes and lots
Lot #s: 20121105-B, 20121112-G
Recall started
Dec. 4, 2012
Recall number
D-321-2013

Cyanocobalamin 1000 mcg/ml…

Product
Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.
Quantity
58 x 30 ml Vials
Codes and lots
Lot: 20121126-H
Recall started
Dec. 4, 2012
Recall number
D-322-2013

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement reports, recall numbers D-321-2013, D-322-2013. The agency record governs; check it and the company before acting.

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