FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility
New England Compounding Center is recalling 23,897 vials of Methylprednisolone Acetate 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 indicates a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Methylprednisolone Acetate (PF) 80 mg/ml Injection manufactured by New England Compounding Center in Framingham, Massachusetts. The recall involves 23,897 vials supplied in 1 mL, 2 mL, and 5 mL sizes. The reason for the recall is non-sterility, which poses a risk of serious adverse health consequences or death.
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 products were distributed nationwide. The recall status is currently terminated, with a termination date of October 7, 2016.
Consumers and healthcare providers should stop using the affected vials immediately. The FDA advises that patients who have received this medication should contact their healthcare provider for guidance. The firm notified customers via email, fax, letter, press release, telephone, and visits.
The recalled product
- Product
- Methylprednisolone Acetate (PF) 80 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
- 23,897
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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