FDA Recalls Depo-Medrol Injectable Due to Temperature Abuse in Manufacturing
McKesson Medical-Surgical is recalling DEPO-MEDROL (methylprednisolone acetate) injectable suspension nationwide due to temperature abuse during manufacturing that may have affected product quality. No illnesses have been reported.
What this means for you
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: FDA Class II recall with no reported illnesses or injuries. Temperature abuse during manufacturing poses a theoretical risk to product quality and efficacy of a prescription medication, meeting the criterion for a risk-of-harm product without yet-reported injury.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling DEPO-MEDROL (methylprednisolone acetate) 40 mg/mL injectable suspension nationwide. The affected product is a prescription corticosteroid used for intra-articular, intralesional, intramuscular, and soft tissue injections.
The recall was initiated due to current Good Manufacturing Practices (cGMP) deviations involving temperature abuse during manufacturing. McKesson Medical-Surgical is unable to identify specific lot numbers received by individual customers, and notification letters have been sent to affected customers with information about distribution and shipment dates.
Healthcare providers and pharmacies should discontinue use of the recalled product immediately and contact their supplier for return instructions. Patients who have received this medication should consult their healthcare provider before making any changes to their treatment. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- DEPO-MEDROL (METHYLPREDNISOLONE ACETATE)
- Brand
- DEPO-MEDROL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Corticosteroid
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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