FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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 40 mg/mL Injection, Preserved, manufactured by New England Compounding Center in Framingham, Massachusetts. The recall involves 5,130 vials supplied in 5 mL and 10 mL sizes. The reason for the recall is non-sterility.
The recall was initiated voluntarily by the firm on September 26, 2012, and was classified as Class I by the FDA on December 31, 2012. The affected products were distributed nationwide. The recall status is currently terminated as of October 7, 2016.
Healthcare providers and consumers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions. The FDA advises that non-sterile injectable products pose a risk of infection.
The recalled product
- Product
- Methylprednisolone Acetate 40 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
- Affected units
- 5,130
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.
See all 17 products in this recall →Related recalls
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