The Recall Desk
SevereFDA (Drugs)·D-1791-2019·Announced 2019-08-21

Infusion Options Recalls Methylprednisolone Due to Sterility Concerns

Infusion Options, Inc. is recalling Methylprednisolone 10 mg/0.16 mL IVP products due to a lack of assurance of sterility. The recall is limited to New York.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Infusion Options, Inc. is recalling Methylprednisolone 10 mg / 0.16 mL IVP, a prescription-only medication. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected products are distributed in New York. The recall includes all lots within their expiration dates. The manufacturer is located in Brooklyn, New York.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Manufacturer
Infusion Options, Inc.
Category
Drug — Injectable Steroid
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 76 recalled by Infusion Options, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 76 products in this recall →

Related recalls

Same manufacturer · Infusion Options, Inc.

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Same hazard · sterility

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