FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 9,062 vials of Methylprednisolone Acetate Injection because they may not be sterile. The recall is nationwide.
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 source text explicitly identifies the recall as FDA Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Methylprednisolone Acetate (PF) 40 mg/ml Injection. The product is supplied in 1 mL, 2 mL, and 5 mL vials and was manufactured by New England Compounding Center in Framingham, Massachusetts. The recall covers 9,062 vials distributed nationwide.
The reason for the recall is non-sterility. The FDA classifies this as a Class I recall, which is the most serious type of recall. This classification indicates a reasonable probability that the use of, or exposure to, the violative product may cause serious adverse health consequences or death. The recall was initiated voluntarily by the firm on September 26, 2012.
Healthcare providers and patients should stop using the affected vials immediately. The recall status is currently terminated, having been closed on October 7, 2016. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
- Manufacturer
- New England Compounding Center
- Category
- Drug — Injection
- Hazard
- Affected units
- 9,062
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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