Injectable Drug Recalled Over Failure to Assure Product Sterility
Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.
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 is an FDA Class II recall of a compounded sterile injectable with no reported illnesses or injuries. The hazard—a manufacturing process that cannot guarantee product sterility—represents a potential contamination risk. Per the rubric, a risk-of-harm product where injury has not yet been reported receives a High (3) score.
Plain-English summary
Vital Care Compounder is recalling a compounded injectable solution containing papaverine, phentolamine, and prostaglandin. FDA inspection determined that the manufacturing process failed to provide adequate assurance of sterility—the products were produced in a manner that cannot guarantee they remained uncontaminated as required for sterile injectable medications.
The recalled product is a 5-mL vial formulation. Two lots are included in this Class II recall: Lot 66450 with a beyond-use date of November 7, 2022, and Lot 66527 with a beyond-use date of November 9, 2022. The medication was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
The recalled product
- Product
- PAPAVERINE / PHENTOLAMINE / PROSTAGLANDIN INJ 90MG/3MG/29.4MCG/ BOTTLE SOLUTION, 5 ML vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Injectable
- Hazard
- contamination-risk
- sterility-assurance
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 (4)
- Lots: 66450
- BUD: 11/07/2022
- 66527
- BUD: 11/09/2022
Distribution
Distributed in 4 states:
- AL
- LA
- MS
- TN
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