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.
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: 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.
See all 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- SevereCrab Cakes Sold to Food Service Recalled for Botulism Risk
FDA (Food) · 2026-04-15
- CriticalUDENYCA syringes recalled after cartons were stored at room temperature
FDA (Drugs) · 2026-02-18