Prescription Corticosteroid Injectable Recalled for Particulate Matter
Sagent Pharmaceuticals recalls methylprednisolone acetate injectable suspension due to potential black particulates in the drug product. Four affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a risk-of-harm injectable product where particulate matter could cause injection-related complications. However, no illnesses or injuries have been reported, which per the rubric limits the severity to High rather than Severe.
Plain-English summary
Sagent Pharmaceuticals has issued a recall of methylprednisolone acetate injectable suspension (40 mg per mL, 1 x 10 mL multi-dose vials) due to the potential presence of black particulate matter in the drug product. The affected lots are 5100186, 5100187, 5100188, and 5100189, with an expiration date of January 31, 2025.
Approximately 14,360 vials were distributed nationwide in the United States. Methylprednisolone acetate is a prescription corticosteroid used for intra-articular, intralesional, intramuscular, and soft tissue injection. The presence of particulates in an injectable product could pose a risk to patients at the injection site.
Healthcare providers and patients who have the affected lots in their possession should stop use immediately and contact their healthcare provider for guidance. The FDA has classified this as a Class II recall. Patients with questions should contact Sagent Pharmaceuticals or consult their healthcare provider.
The recalled product
- Product
- METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
- Brand
- METHYLPREDNISOLONE ACETATE
- Manufacturer
- Sagent Pharmaceuticals
- Category
- Drug — Injectable Corticosteroid
- Hazard
- Affected units
- 14,360
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 (5)
- Lots 5100186
- 5100187
- 5100188
- 5100189
- Exp 01/31/2025
Distribution
Distributed nationwide across the United States.
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