FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 3,822 vials of Methylprednisolone Acetate 80 mg/mL Injection nationwide due to non-sterility concerns.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Methylprednisolone Acetate 80 mg/mL Injection, Preserved, manufactured by New England Compounding Center in Framingham, Massachusetts. The recall involves 3,822 vials supplied in 5 mL and 10 mL sizes. The reason for the recall is non-sterility, which indicates the product may not be free from microorganisms.
The recall was initiated voluntarily by the firm on September 26, 2012, and is classified as Class I, the most serious type of recall. The affected product was distributed nationwide. The recall status is currently terminated, with a termination date of October 7, 2016.
Healthcare providers and patients should stop using the affected vials and contact the manufacturer or their healthcare provider for further instructions. The FDA advises that non-sterile injectable products can pose a risk of infection if administered.
The recalled product
- Product
- Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 3,822
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by New England Compounding Center 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.
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