Injectable Steroid Suspension Recalled Due to Manufacturing Temperature Control Deviation
Celestone Soluspan injectable suspension is being recalled for manufacturing temperature control deviations that violated good manufacturing practices. McKesson distributed 51 vials 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 FDA Class II recall involves manufacturing deviations related to temperature control of an injectable medication. The deviation affects a critical control point for injectable drug safety, representing a risk-of-harm scenario despite no reported adverse events in the source.
Plain-English summary
Celestone Soluspan is an injectable suspension manufactured by Merck Company. The recalled product comprises 51 multidose vials distributed nationwide by McKesson Medical-Surgical Inc.
The recall was initiated due to cGMP (current Good Manufacturing Practice) deviations involving temperature abuse during manufacturing. Temperature control during manufacturing is essential to preserve the integrity and safety characteristics of injectable medications.
The product was distributed nationwide throughout the United States. McKesson notes that it is unable to identify specific lot numbers for individual customers; however, each notification letter provided includes the distribution dates and shipment dates relevant to each location.
This recall was classified as FDA Class II.
The recalled product
- Product
- Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Suspension
- Affected units
- 51
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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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